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Dajani O, Philips I, Størkson E, Balstad T, Brown L, Bye A, Dolan R, Greil C, Hjermstad M, Jakobsen G, Kaasa S, McDonald J, Ottestad I, Sayers J, Simpson M, Sousa M, Vagnildhaug O, Yule M, Laird B, Skipworth R, Solheim T, Stares M, Arends J, the Cancer Cachexia Endpoints Working Group. Oncological and Survival Endpoints in Cancer Cachexia Clinical Trials: Systematic Review 6 of the Cachexia Endpoints Series. J Cachexia Sarcopenia Muscle 2025; 16:e13756. [PMID: 40065459 PMCID: PMC11893360 DOI: 10.1002/jcsm.13756] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/07/2024] [Revised: 01/29/2025] [Accepted: 02/05/2025] [Indexed: 03/14/2025] Open
Abstract
BACKGROUND In patients receiving anti-cancer treatment, cachexia results in poorer oncological outcomes. However, there is limited understanding and no systematic review of oncological endpoints in cancer cachexia (CC) trials. This review examines oncological endpoints in CC clinical trials. METHODS An electronic literature search of MEDLINE, Embase and Cochrane databases (1990-2023) was performed. Eligibility criteria comprised participants ≥ 18 years old; controlled design; ≥ 40 participants; and a cachexia intervention for > 14 days. Trials reporting at least one oncological endpoint were selected for analysis. Data extraction was performed using Covidence and followed PRISMA guidelines and the review was registered (PROSPERO CRD42022276710). RESULTS Fifty-seven trials were eligible, totalling 9743 patients (median: 107, IQR: 173). Twenty-six (46%) trials focussed on a single tumour site: eight in lung, six in pancreatic, six in head and neck and six in GI cancers. Forty-two (74%) studies included patients with Stage III/IV disease, and 41 (70%) included patients receiving palliative anti-cancer treatment. Ten studies (18%) involved patients on curative treatment. Twenty-eight (49%) studies used pharmacological interventions, 29 (50%) used oral nutrition, and two (4%) used enteral or parenteral nutrition. Reported oncological endpoints included overall survival (OS, n = 46 trials), progression-free survival (PFS, n = 7), duration of response (DR, n = 1), response rate (RR, n = 9), completion of treatment (TC, n = 11) and toxicity/adverse events (AE, n = 42). Median OS differed widely from 60 to 3468 days. Of the 46 studies, only three reported a significant positive effect on survival. Seven trials showed a difference in AE, four in TC, one in PFS and one in RR. Reported significances were unreliable due to missing adjustments for extensive multiple testing. Only three of the six trials using OS as the primary endpoint reported pre-trial sample size calculations, but only one recruited the planned number of patients. CONCLUSION In CC trials, oncological endpoints were mostly secondary and only few significant findings have been reported. Due to heterogeneity in oncological settings, nutritional and metabolic status and interventions, firm conclusions about CC treatment are not possible. OS and AE are relevant endpoints, but future trials targeting clinically meaningful hazard ratios will required more homogeneous patient cohorts, adequate pre-trial power analyses and adherence to statistical testing standards.
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Affiliation(s)
- Olav Dajani
- Regional Advisory Unit for Palliative Care, Dept. of Oncology, Oslo University Hospital/European Palliative Care Research Centre (PRC), Dept. of Oncology, Oslo University Hospital, and Institute of Clinical MedicineUniversity of OsloOsloNorway
| | - Iain Philips
- Edinburgh Cancer Research Centre, Institute of Genetics and CancerUniversity of EdinburghEdinburghUK
| | - Ester Kristine Størkson
- Regional Advisory Unit for Palliative Care, Dept. of Oncology, Oslo University Hospital/European Palliative Care Research Centre (PRC), Dept. of Oncology, Oslo University Hospital, and Institute of Clinical MedicineUniversity of OsloOsloNorway
| | - Trude R. Balstad
- Department of Clinical Medicine, Clinical Nutrition Research GroupUiT The Arctic University of NorwayTromsøNorway
- Department of Clinical and Molecular Medicine, Faculty of Medicine and Health SciencesNTNU ‐ Norwegian University of Science and TechnologyTrondheimNorway
| | - Leo R. Brown
- Royal Infirmary of EdinburghClinical Surgery University of EdinburghEdinburghUK
| | - Asta Bye
- Department of Nursing and Health Promotion, Faculty of Health SciencesOslo Metropolitan UniversityOsloNorway
| | - Ross Dolan
- Academic Unit of SurgeryUniversity of Glasgow, Glasgow Royal InfirmaryGlasgowUK
| | - Christine Greil
- Department of Medicine I, Medical Center ‐ University of Freiburg, Faculty of MedicineUniversity of FreiburgFreiburgGermany
| | - Marianne Hjermstad
- Regional Advisory Unit for Palliative Care, Dept. of Oncology, Oslo University Hospital/European Palliative Care Research Centre (PRC), Dept. of Oncology, Oslo University Hospital, and Institute of Clinical MedicineUniversity of OsloOsloNorway
| | - Gunnhild Jakobsen
- Department of Public Health and NursingNorwegian University of Science and TechnologyTrondheimNorway
| | - Stein Kaasa
- Regional Advisory Unit for Palliative Care, Dept. of Oncology, Oslo University Hospital/European Palliative Care Research Centre (PRC), Dept. of Oncology, Oslo University Hospital, and Institute of Clinical MedicineUniversity of OsloOsloNorway
| | - James McDonald
- Edinburgh Cancer Research Centre, Institute of Genetics and CancerUniversity of EdinburghEdinburghUK
| | - Inger Ottestad
- Department of Nutrition, Institute of Basic Medical Sciences, Faculty of MedicineUniversity of OsloOsloNorway
- The Clinical Nutrition Outpatient Clinic, Section of Clinical Nutrition, Department of Clinical Service, Division of Cancer MedicineOslo University HospitalOsloNorway
| | - Judith Sayers
- Edinburgh Cancer Research Centre, Institute of Genetics and CancerUniversity of EdinburghEdinburghUK
- Palliative CareSt Columba's Hospice CareEdinburghUK
| | - Melanie Simpson
- Department of Public Health and NursingNorwegian University of Science and TechnologyTrondheimNorway
| | - Mariana S. Sousa
- Improving Palliative, Aged and Chronic Care Through Clinical Research and Translation (IMPACCT)University of Technology SydneySydneyAustralia
| | - Ola Magne Vagnildhaug
- Department of Clinical and Molecular Medicine, Faculty of Medicine and Health SciencesNTNU ‐ Norwegian University of Science and TechnologyTrondheimNorway
- Cancer ClinicSt Olav's Hospital ‐ Trondheim University HospitalTrondheimNorway
| | - Michael S. Yule
- Edinburgh Cancer Research Centre, Institute of Genetics and CancerUniversity of EdinburghEdinburghUK
- Palliative CareSt Columba's Hospice CareEdinburghUK
| | - Barry J. A. Laird
- Edinburgh Cancer Research Centre, Institute of Genetics and CancerUniversity of EdinburghEdinburghUK
- Palliative CareSt Columba's Hospice CareEdinburghUK
| | | | - Tora S. Solheim
- Department of Clinical and Molecular Medicine, Faculty of Medicine and Health SciencesNTNU ‐ Norwegian University of Science and TechnologyTrondheimNorway
- Cancer ClinicSt Olav's Hospital ‐ Trondheim University HospitalTrondheimNorway
| | - Mark Stares
- Edinburgh Cancer Research Centre, Institute of Genetics and CancerUniversity of EdinburghEdinburghUK
| | - Jann Arends
- Department of Medicine I, Medical Center ‐ University of Freiburg, Faculty of MedicineUniversity of FreiburgFreiburgGermany
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Bowers M, Petrasso C, McLuskie A, Bayly J, Laird B, Higginson I, Maddocks M. Multicomponent Interventions for Adults With Cancer Cachexia: A Systematic Review. J Cachexia Sarcopenia Muscle 2025; 16:e13716. [PMID: 40012451 PMCID: PMC11865637 DOI: 10.1002/jcsm.13716] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/14/2024] [Revised: 11/26/2024] [Accepted: 12/25/2024] [Indexed: 02/28/2025] Open
Abstract
BACKGROUND Cancer cachexia has substantial impacts on people's quality of life. There is no current gold standard treatment, but the complex pathophysiology of cachexia suggests that a multitargeted and individualised treatment approach is needed. We aimed to evaluate the extent to which multicomponent interventions have targeted the key features of cachexia and been tailored to individuals, and differential effects on quality of life. METHODS We conducted a systematic review of multicomponent interventions for adults with cancer cachexia. We searched four databases, two clinical trial registers and MedRxiv on 20 June 2024. Intervention components were classified by intervention category (nutritional, exercise/physical activity, pharmacological and psychosocial), cachexia feature(s) targeted (reduced energy intake, altered metabolism, involuntary weight loss and decline in physical function) and level of tailoring. Within-arm standardised mean changes in quality of life over time, as well as standardised mean differences between study arms, were calculated. RESULTS Sixty-two multicomponent interventions were included, of which two combined components from all four intervention categories, and nine targeted all four key features of cachexia. Eighteen multicomponent interventions were fully tailored and 30 were partly tailored to individuals. Within-arm standardised mean changes in quality of life were calculated for thirteen studies; all had a high risk of bias or raised concerns. In eleven studies, quality of life scores improved following the intervention, whereas in two studies they declined. Standardised mean differences between study arms were calculated for four studies; in three, the intervention arm showed a greater improvement in quality of life scores than the usual care arm. Amongst these data, there was no indication that the number of cachexia features targeted, or the extent of tailoring, was associated with a greater improvement in quality of life scores; however, the heterogeneity prevented us from concluding on our hypothesis. CONCLUSIONS This review mapped out in detail the combinations of intervention categories used, the key features of cachexia targeted, and the extent of tailoring across multicomponent interventions for adults with cancer cachexia. Only a small proportion of the multicomponent interventions targeted all four key features of cachexia, but most were either partly or fully tailored to individuals. Despite sixty-two multicomponent interventions being investigated, only four studies compared these to usual care and reported quality of life outcomes. High risk of bias, low sample sizes and variable outcome data remain challenges to the interpretability of results in this field.
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Affiliation(s)
- Megan Bowers
- Cicely Saunders Institute of Palliative Care, Policy & Rehabilitation, Florence Nightingale Faculty of Nursing, Midwifery & Palliative CareKing's College LondonLondonUK
| | - Carmine Petrasso
- Cicely Saunders Institute of Palliative Care, Policy & Rehabilitation, Florence Nightingale Faculty of Nursing, Midwifery & Palliative CareKing's College LondonLondonUK
| | - Amy McLuskie
- Edinburgh Palliative Care and Supportive Care GroupThe University of EdinburghEdinburghUK
| | - Joanne Bayly
- Cicely Saunders Institute of Palliative Care, Policy & Rehabilitation, Florence Nightingale Faculty of Nursing, Midwifery & Palliative CareKing's College LondonLondonUK
| | - Barry J. A. Laird
- Edinburgh Palliative Care and Supportive Care GroupThe University of EdinburghEdinburghUK
- St Columba's HospiceEdinburghUK
| | - Irene J. Higginson
- Cicely Saunders Institute of Palliative Care, Policy & Rehabilitation, Florence Nightingale Faculty of Nursing, Midwifery & Palliative CareKing's College LondonLondonUK
| | - Matthew Maddocks
- Cicely Saunders Institute of Palliative Care, Policy & Rehabilitation, Florence Nightingale Faculty of Nursing, Midwifery & Palliative CareKing's College LondonLondonUK
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Allan L, Hatchett N, Skene SS, Eastley KB, Michael A. Management of inoperable malignant bowel obstruction using the 4-step BOUNCED diet. J Hum Nutr Diet 2025; 38:e13388. [PMID: 39498793 DOI: 10.1111/jhn.13388] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/07/2024] [Revised: 10/08/2024] [Accepted: 10/18/2024] [Indexed: 11/07/2024]
Abstract
BACKGROUND Malignant bowel obstruction (MBO) presents with multiple symptoms. The 4-step BOUNCED diet educates patients to self-manage oral intake according to symptoms. It includes clear fluids, thin liquids, purée and soft, sloppy foods, which are low in fibre. METHODS This mixed methods single-arm feasibility study aimed to establish if the diet could reduce MBO symptoms in patients with inoperable colorectal and gynaecological malignancies. The secondary objectives were to investigate if it was easily followed, improved quality of life (QOL) and reduced hospital admissions. Patients able to tolerate an oral diet with one or more symptoms (pain, bloating, early satiety, nausea and vomiting) were eligible. Following informed consent, an oncology dietitian took a diet history and determined which step of the diet they needed to follow using a detailed patient information leaflet. Patients remained on the trial for 28 days. Symptom and QOL data were collected on Days 1 and 28 using the Memorial Symptom Assessment Scale and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) questionnaires. RESULTS Thirty patients (24 female, 6 male) aged 18-85 years consented from March 2021 to November 2022. Twenty-six participants completed the trial and 25 found the diet very easy or easy to understand. There was a significant reduction in pain from 96% on Day 1 to 63% on Day 28 (p = 0.004). The mean increase of EORTC global health status/QOL was 23.5 points, 95% CI (12.4-32.5) (p ≤ 0.001). There was a significant difference between number of admissions (p = 0.018) and bed days (p = 0.004) in the 28 days prior to consent compared to the trial period. CONCLUSIONS A modified consistency low-fibre diet is easily followed, may reduce symptoms of MBO, admissions to hospital and improve QOL.
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Affiliation(s)
- Lindsey Allan
- Department of Nutrition and Dietetics, Royal Surrey NHS Foundation Trust, Guildford, UK
| | - Naomi Hatchett
- Department of Nutrition and Dietetics, Royal Surrey NHS Foundation Trust, Guildford, UK
| | - Simon S Skene
- Surrey Clinical Trials Unit, School of Biosciences, University of Surrey, Guildford, UK
| | - Kate Bennett Eastley
- Surrey Clinical Trials Unit, School of Biosciences, University of Surrey, Guildford, UK
| | - Agnieszka Michael
- Department of Nutrition and Dietetics, Royal Surrey NHS Foundation Trust, Guildford, UK
- Surrey Clinical Trials Unit, School of Biosciences, University of Surrey, Guildford, UK
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Cotogni P, De Carli L. Near-Death Quality of Life in Cancer Patients on Home Parenteral Nutrition. Nutrients 2025; 17:271. [PMID: 39861401 PMCID: PMC11767650 DOI: 10.3390/nu17020271] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/08/2024] [Revised: 12/28/2024] [Accepted: 01/10/2025] [Indexed: 01/27/2025] Open
Abstract
Background: The impact of home parenteral nutrition (HPN) on the quality of life (QoL) of cancer patients has been previously investigated. However, scarce data are available regarding near-death QoL in patients with cancer receiving HPN. This study aims to investigate the changes of QoL in these patients in the last two months before death. Methods: This is a secondary analysis of a previous, prospective, longitudinal, observational study. QoL was assessed using the EORTC QLQ-C30 questionnaire. Results: Eighty-four adult cancer patients who died on HPN and had filled out the questionnaire between 31 and 60 days (M2) and within 30 days prior (M1) to death were included in this analysis. The questionnaires filled out at M2 and M1 were compared with those filled out by the same patients at HPN start (T0). At M2, there was a significant improvement in both the global QoL and symptoms scales (p < 0.001 and p < 0.033, respectively), while at M1, a significant improvement in the global QoL scale persisted (p < 0.035) compared with T0. Conclusions: Our study first reports that HPN, if started early and according to European guidelines, is associated with an improvement in the QoL of patients with cancer even in the last two months before death.
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Affiliation(s)
- Paolo Cotogni
- Pain Management and Palliative Care, Department of Anesthesia, Intensive Care and Emergency, Molinette Hospital, University of Turin, 10126 Turin, Italy
| | - Luca De Carli
- Clinical Nutrition Unit, ASL Città di Torino, 10128 Turin, Italy;
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Mcluskie A, Bowers M, Bayly J, Yule MS, Maddocks M, Fallon M, Skipworth RJ, Laird BJA. Nutritional interventions in randomised clinical trials for people with incurable solid cancer: A systematic review. Clin Nutr 2025; 44:201-219. [PMID: 39708462 DOI: 10.1016/j.clnu.2024.12.008] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/26/2024] [Revised: 11/13/2024] [Accepted: 12/03/2024] [Indexed: 12/23/2024]
Abstract
BACKGROUND & AIMS Malnutrition is highly prevalent in those with cancer and more so in those with incurable cancer. In incurable cancer, it is widely agreed that optimal nutritional care has the potential to positively impact patient and caregiver distress and oncological outcomes. The aim of this systematic review was to describe the diversity and frequency of nutritional interventions, whether given in isolation or as part of a multimodal intervention in those with incurable cancer, in randomised controlled trials. The secondary aims were to describe adherence and their efficacy. METHODS This systematic review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) guidelines. The following databases were searched electronically: Medical Literature Analysis and Retrieval System Online (MEDLINE), Excerpta Medica database (EMBASE), Cumulated Index to Nursing and Allied Health Literature (CINAHL) and Cochrane Central Register of Controlled Trials (CENTRAL) with the time frame from January 2000 to 7th September 2023. Eligible studies included adult patients (≥18 years) diagnosed with incurable solid cancer with a sample size ≥40. Studies were to be primary research and delivered for at least 14 days to allow for efficacy. They were to include a nutritional intervention encompassing at least one of the following: dietary counselling, oral nutritional supplements (ONS), enteral tube feeding and/or parenteral nutrition (PN), given in isolation or as part of a multi-modal intervention. Studies were excluded if the population contained patients who had completed curative treatment or are being treated with curative intent, haematological cancers, or if they examined the effects of micronutrients, proteins, amino acids or fatty acids given in isolation. The quality of the included studies was assessed using the Cochrane risk of bias tool for randomised trials (RoB2). A balloon plot was produced to present the results in addition to a table with a narrative summary of the primary outcomes. RESULTS A total of 7968 studies were identified, of which 18 met the eligibility criteria. This included 2720 study participants. The included studies comprised: multimodal interventions (n = 7), dietary counselling (n = 2), nutritional supplementation with or without dietary counselling (n = 7) and PN (n = 2). Primary outcomes included quality of life (QoL), body composition and nutritional status. For QoL, this was reported in 15 studies, 4 studies showed a significant improvement. Body composition was evaluated in 15 studies, 5 of which showed a significant improvement in body weight and two in fat-free mass (FFM). Nutritional status was reported in 6 studies with one showing a significant difference in Patient-Generated Subjective Global Assessment (PG-SGA) score. The risk of bias was deemed 'low' in 6 studies, with 'some concerns' in 10 studies and a 'high risk' in 2 studies. There was heterogeneity between the studies. CONCLUSION This systematic review has highlighted some positive findings in regard to QoL, body weight and nutritional intake. Optimum nutritional intervention was not identified. Future studies should evaluate the effectiveness of earlier nutritional interventions at the point of diagnosis, including regular reviews and the impact this has on nutritional outcomes, QoL and overall survival (OS).
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Affiliation(s)
- Amy Mcluskie
- Edinburgh Cancer Research Centre, University of Edinburgh, Edinburgh, UK.
| | - Megan Bowers
- Cicely Saunders Institute of Palliative Care, Policy and Rehabilitation, Kings College, London, UK
| | - Jo Bayly
- Cicely Saunders Institute of Palliative Care, Policy and Rehabilitation, Kings College, London, UK
| | - Michael S Yule
- Edinburgh Cancer Research Centre, University of Edinburgh, Edinburgh, UK; St Columba's Hospice, Boswall Road, Edinburgh, UK
| | - Matthew Maddocks
- Cicely Saunders Institute of Palliative Care, Policy and Rehabilitation, Kings College, London, UK
| | - Marie Fallon
- Edinburgh Cancer Research Centre, University of Edinburgh, Edinburgh, UK
| | - Richard Je Skipworth
- Clinical Surgery, Royal Infirmary of Edinburgh, University of Edinburgh, Edinburgh, UK
| | - Barry J A Laird
- Edinburgh Cancer Research Centre, University of Edinburgh, Edinburgh, UK; St Columba's Hospice, Boswall Road, Edinburgh, UK.
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Huang X, Cui C, Wang J, Kong D, Cui Y, Huang P, Li X. The effect of preoperative supplementary parenteral nutrition on nutrition and inflammation in gastric cancer patients. Discov Oncol 2024; 15:400. [PMID: 39225821 PMCID: PMC11372033 DOI: 10.1007/s12672-024-01288-3] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/30/2024] [Accepted: 08/29/2024] [Indexed: 09/04/2024] Open
Abstract
OBJECTIVES Supplemental parenteral nutrition (SPN) is recommended to add when enteral nutrition alone is not sufficient. This research aims to evaluate the effect of preoperative SPN in patients with gastric cancer. METHODS A total of 180 patients with gastric cancer were divided into three groups (60 patients per group) according to different nutritional support scheme. The primary endpoint was the changes in nutrition and inflammatory, while the secondary endpoint included the changes in prognosis. RESULTS Compared with the control group, there were significant differences in nutrition and inflammation related indicators in the oral nutrition supplement (ONS) group and the SPN + ONS group (P < 0.05). Compared with the ONS group, the SPN + ONS group showed significant differences in the above indicators (P < 0.05). However, no significant changes were observed in the incidence of complications, the postoperative exhaust time, and the hospitalization time. CONCLUSIONS Preoperative SPN had a positive effect on nutrition and inflammation of gastric cancer patients undergoing surgery, but had no significant effect on their prognosis.
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Affiliation(s)
- Xiaoyan Huang
- Department of Nursing, Yantai Yuhuangding Hospital, Shandong, 264000, China
| | - Changxing Cui
- Department of Nursing, Yantai Yuhuangding Hospital, Shandong, 264000, China
| | - Jing Wang
- Department of Surgery, Yantai Yuhuangding Hospital, Shandong, 264000, China
| | - Dongchi Kong
- Department of Clinical Nutrition, Yantai Yuhuangding Hospital, Shandong, 264000, China
| | - Yuanqing Cui
- Department of Surgery, Yantai Yuhuangding Hospital, Shandong, 264000, China.
| | - Peng Huang
- Department of Internal Medicine, Yantai Yuhuangding Hospital, Shandong, 264000, China.
| | - Xuelong Li
- Department of Clinical Nutrition, Yantai Yuhuangding Hospital, Shandong, 264000, China.
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Firouzabadi D, Ahmadi H. Cancer-Related Malnutrition and the Role of Parenteral Nutrition in Cancer; A Narrative Review. Nutr Cancer 2024; 76:870-884. [PMID: 39039741 DOI: 10.1080/01635581.2024.2381271] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/14/2023] [Revised: 07/09/2024] [Accepted: 07/10/2024] [Indexed: 07/24/2024]
Abstract
The growing incidence rate of cancer and its associated morbidity and mortality prompts the need to identify factors that could improve the quality of life (QoL) and survival of a patient with cancer. Cancer-associated malnutrition is a common complication that could start at the early stages of cancer and could further develop into advanced cachexia. Response to treatment, length of hospital stay, progression of infection, and other complications of cancer including chemotherapy adverse events could all be influenced by the progression of malnutrition. Nutritional interventions may vary from oral to enteral and parenteral therapy. Parenteral nutrition (PN) therapy may benefit patients at certain stages of cancer in whom contraindications or inefficacy of other modalities of nutritional support are present. This method may seem invasive, costly, and risky but at the same time may improve certain patients' QoL and chance of survival. In trained settings with proper facilities, this method of nutritional support can benefit patients; However, the indication for starting PN must be carefully supervised considering that other nutritional support methods may be equally efficient and at the same time easier to access and apply.
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Affiliation(s)
- Dena Firouzabadi
- Clinical Pharmacy Department, Shiraz School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran
| | - Hossein Ahmadi
- Clinical Pharmacy Department, Shiraz School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran
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Ueno K, Nishigori T, Tokoro Y, Nakakura A, Tsunoda S, Hisamori S, Hashimoto K, Kanaya S, Hirai K, Tanaka E, Hata H, Manaka D, Sakaguchi M, Kondo M, Kan T, Itami A, Miki A, Kawamura Y, Toda K, Okabe H, Yamamoto M, Yamashita Y, Kinjo Y, Kawada H, Obama K. The efficacy of simple oral nutritional supplements versus usual care in postoperative patients with gastric cancer: study protocol for a multicenter, open-label, parallel, randomized controlled trial. Trials 2024; 25:445. [PMID: 38961505 PMCID: PMC11223300 DOI: 10.1186/s13063-024-08169-8] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/25/2023] [Accepted: 05/09/2024] [Indexed: 07/05/2024] Open
Abstract
BACKGROUND Body weight loss (BWL) after gastrectomy impact on the short- and long-term outcomes. Oral nutritional supplement (ONS) has potential to prevent BWL in patients after gastrectomy. However, there is no consistent evidence supporting the beneficial effects of ONS on BWL, muscle strength and health-related quality of life (HRQoL). This study aimed to evaluate the effects of ONS formulated primarily with carbohydrate and protein on BWL, muscle strength, and HRQoL. METHODS This will be a multicenter, open-label, parallel, randomized controlled trial in patients with gastric cancer who will undergo gastrectomy. A total of 120 patients who will undergo gastrectomy will be randomly assigned to the ONS group or usual care (control) group in a 1:1 ratio. The stratification factors will be the clinical stage (I or ≥ II) and surgical procedures (total gastrectomy or other procedure). In the ONS group, the patients will receive 400 kcal (400 ml)/day of ONS from postoperative day 5 to 7, and the intervention will continue postoperatively for 8 weeks. The control group patients will be given a regular diet. The primary outcome will be the percentage of BWL (%BWL) from baseline to 8 weeks postoperatively. The secondary outcomes will be muscle strength (handgrip strength), HRQoL (EORTC QLQ-C30, QLQ-OG25, EQ-5D-5L), nutritional status (hemoglobin, lymphocyte count, albumin), and dietary intake. All analyses will be performed on an intention-to-treat basis. DISCUSSION This study will provide evidence showing whether or not ONS with simple nutritional ingredients can improve patient adherence and HRQoL by reducing BWL after gastrectomy. If supported by the study results, nutritional support with simple nutrients will be recommended to patients after gastrectomy for gastric cancer. TRIAL REGISTRATION jRCTs051230012; Japan Registry of Clinical Trails. Registered on Apr. 13, 2023.
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Affiliation(s)
- Kohei Ueno
- Department of Surgery, Kyoto University Hospital, 54 Shogoinkawahara-Cho, Sakyo-Ku, Kyoto, 606-8507, Japan
| | - Tatsuto Nishigori
- Department of Surgery, Kyoto University Hospital, 54 Shogoinkawahara-Cho, Sakyo-Ku, Kyoto, 606-8507, Japan.
| | - Yukinari Tokoro
- Department of Surgery, Kyoto University Hospital, 54 Shogoinkawahara-Cho, Sakyo-Ku, Kyoto, 606-8507, Japan
| | - Akiyoshi Nakakura
- Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan
| | - Shigeru Tsunoda
- Department of Surgery, Kyoto University Hospital, 54 Shogoinkawahara-Cho, Sakyo-Ku, Kyoto, 606-8507, Japan
| | - Shigeo Hisamori
- Department of Surgery, Kyoto University Hospital, 54 Shogoinkawahara-Cho, Sakyo-Ku, Kyoto, 606-8507, Japan
| | | | | | - Kenjiro Hirai
- Department of Surgery, Japanese Red Cross Otsu Hospital, Shiga, Japan
| | - Eiji Tanaka
- Department of Surgery, The Tazuke Kofukai Medical Research Institute, Kitano Hospital, Osaka, Japan
| | - Hiroaki Hata
- Department of Surgery, National Hospital Organization Kyoto Medical Center, Kyoto, Japan
| | - Dai Manaka
- Department of Surgery, Kyoto Katsura Hospital, Kyoto, Japan
| | | | - Masato Kondo
- Department of Surgery, Kobe City Medical Center, General Hospital, Hyogo, Japan
| | - Takatsugu Kan
- Department of Surgery, Kobe City Medical Center, West Hospital, Hyogo, Japan
| | - Atsushi Itami
- Department of Surgery, Kobe City Nishi-Kobe Medical Center, Hyogo, Japan
| | - Akira Miki
- Department of Surgery, Toyooka Hospital, Hyogo, Japan
| | | | - Kosuke Toda
- Department of Surgery, Shiga General Hospital, Shiga, Japan
| | - Hiroshi Okabe
- Department of Surgery, New Tokyo Hospital, Chiba, Japan
| | | | - Yoshito Yamashita
- Department of Surgery, Japanese Red Cross Wakayama Medical Center, Wakayama, Japan
| | - Yosuke Kinjo
- Department of Surgery, National Hospital Organization Himeji Medical Center, Hyogo, Japan
| | - Hironori Kawada
- Department of Surgery, Hyogo Prefectural Amagasaki General Medical Center, Hyogo, Japan
| | - Kazutaka Obama
- Department of Surgery, Kyoto University Hospital, 54 Shogoinkawahara-Cho, Sakyo-Ku, Kyoto, 606-8507, Japan
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Hjermstad MJ, Jakobsen G, Arends J, Balstad TR, Brown LR, Bye A, Coats AJ, Dajani OF, Dolan RD, Fallon MT, Greil C, Grzyb A, Kaasa S, Koteng LH, May AM, McDonald J, Ottestad I, Philips I, Roeland EJ, Sayers J, Simpson MR, Skipworth RJ, Solheim TS, Sousa MS, Vagnildhaug OM, Laird BJ, the Cancer Cachexia Endpoints Working Group. Quality of life endpoints in cancer cachexia clinical trials: Systematic review 3 of the cachexia endpoints series. J Cachexia Sarcopenia Muscle 2024; 15:794-815. [PMID: 38553255 PMCID: PMC11154790 DOI: 10.1002/jcsm.13453] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/14/2023] [Revised: 12/22/2023] [Accepted: 02/14/2024] [Indexed: 06/07/2024] Open
Abstract
The use of patient-reported outcomes (PROMs) of quality of life (QOL) is common in cachexia trials. Patients' self-report on health, functioning, wellbeing, and perceptions of care, represent important measures of efficacy. This review describes the frequency, variety, and reporting of QOL endpoints used in cancer cachexia clinical trials. Electronic literature searches were performed in Medline, Embase, and Cochrane (1990-2023). Seven thousand four hundred thirty-five papers were retained for evaluation. Eligibility criteria included QOL as a study endpoint using validated measures, controlled design, adults (>18 years), ≥40 participants randomized, and intervention exceeding 2 weeks. The Covidence software was used for review procedures and data extractions. Four independent authors screened all records for consensus. Papers were screened by titles and abstracts, prior to full-text reading. PRISMA guidance for systematic reviews was followed. The protocol was prospectively registered via PROSPERO (CRD42022276710). Fifty papers focused on QOL. Twenty-four (48%) were double-blind randomized controlled trials. Sample sizes varied considerably (n = 42 to 469). Thirty-nine trials (78%) included multiple cancer types. Twenty-seven trials (54%) featured multimodal interventions with various drugs and dietary supplements, 11 (22%) used nutritional interventions alone and 12 (24%) used a single pharmacological intervention only. The median duration of the interventions was 12 weeks (4-96). The most frequent QOL measure was the EORTC QLQ-C30 (60%), followed by different FACIT questionnaires (34%). QOL was a primary, secondary, or exploratory endpoint in 15, 31 and 4 trials respectively, being the single primary in six. Statistically significant results on one or more QOL items favouring the intervention group were found in 18 trials. Eleven of these used a complete multidimensional measure. Adjustments for multiple testing when using multicomponent QOL measures were not reported. Nine trials (18%) defined a statistically or clinically significant difference for QOL, five with QOL as a primary outcome, and four with QOL as a secondary outcome. Correlation statistics with other study outcomes were rarely performed. PROMs including QOL are important endpoints in cachexia trials. We recommend using well-validated QOL measures, including cachexia-specific items such as weight history, appetite loss, and nutritional intake. Appropriate statistical methods with definitions of clinical significance, adjustment for multiple testing and few co-primary endpoints are encouraged, as is an understanding of how interventions may relate to changes in QOL endpoints. A strategic and scientific-based approach to PROM research in cachexia trials is warranted, to improve the research base in this field and avoid the use of QOL as supplementary measures.
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Affiliation(s)
- Marianne J. Hjermstad
- Department of OncologyOslo University HospitalOsloNorway
- European Palliative Care Research Centre (PRC), Department of Oncology, Oslo University Hospital, and Institute of Clinical MedicineUniversity of OsloOsloNorway
| | - Gunnhild Jakobsen
- Department of Public Health and Nursing, Faculty of Medicine and Health SciencesNorwegian University of Science and Technology (NTNU)OsloNorway
- Cancer Clinic, St. Olavs HospitalTrondheim University HospitalTrondheimNorway
| | - Jann Arends
- Department of Medicine I, Faculty of MedicineUniversity of FreiburgFreiburgGermany
| | - Trude R. Balstad
- Department of Clinical and Molecular Medicine, Faculty of Medicine and Health SciencesNTNU–Norwegian University of Science and TechnologyTrondheimNorway
- Department of Clinical Medicine, Clinical Nutrition Research Group, UiTThe Arctic University of NorwayTromsøNorway
| | - Leo R. Brown
- Department of Clinical SurgeryUniversity of EdinburghEdinburghUK
- Royal Infirmary of EdinburghEdinburghUK
| | - Asta Bye
- Department of OncologyOslo University HospitalOsloNorway
- Department of Nursing and Health Promotion, Faculty of Health SciencesOsloMet – Oslo Metropolitan UniversityOsloNorway
| | | | - Olav F. Dajani
- Department of OncologyOslo University HospitalOsloNorway
| | - Ross D. Dolan
- Academic Unit of SurgeryUniversity of Glasgow, Glasgow Royal InfirmaryGlasgowUK
| | - Marie T. Fallon
- Edinburgh Cancer Research CentreUniversity of EdinburghEdinburghUK
- St Columba's HospiceEdinburghUK
| | - Christine Greil
- Department of Medicine I, Faculty of MedicineUniversity of FreiburgFreiburgGermany
| | | | - Stein Kaasa
- Department of OncologyOslo University HospitalOsloNorway
- European Palliative Care Research Centre (PRC), Department of Oncology, Oslo University Hospital, and Institute of Clinical MedicineUniversity of OsloOsloNorway
| | - Lisa H. Koteng
- Department of OncologyOslo University HospitalOsloNorway
| | - Anne M. May
- Julius Center for Health Sciences and Primary Care, University Medical Center UtrechtUtrecht UniversityUtrechtThe Netherlands
| | | | - Inger Ottestad
- Department of Nutrition, Institute of Basic Medical SciencesUniversity of OsloOsloNorway
- Department of Clinical Service, Division of Cancer Medicine, Section of Clinical NutritionOslo University HospitalOsloNorway
| | - Iain Philips
- Edinburgh Cancer Research CentreUniversity of EdinburghEdinburghUK
| | - Eric J. Roeland
- Oregon Health and Science UniversityKnight Cancer InstitutePortlandORUSA
| | - Judith Sayers
- Academic Unit of SurgeryUniversity of Glasgow, Glasgow Royal InfirmaryGlasgowUK
| | - Melanie R. Simpson
- Department of Public Health and NursingNorwegian University of Science and TechnologyTrondheimNorway
| | | | - Tora S. Solheim
- Department of Public Health and Nursing, Cancer Clinic, St Olavs HospitalTrondheim University HospitalTrondheimNorway
- Department of Clinical and Molecular MedicineNorwegian University of Science and TechnologyTrondheimNorway
| | - Mariana S. Sousa
- Improving Palliative, Aged and Chronic Care through Clinical Research and Translation (IMPACCT)University of TechnologySydneyNSWAustralia
| | - Ola M. Vagnildhaug
- Department of Public Health and Nursing, Cancer Clinic, St Olavs HospitalTrondheim University HospitalTrondheimNorway
- Department of Clinical and Molecular MedicineNorwegian University of Science and TechnologyTrondheimNorway
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10
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Bozzetti F. The role of the nutrition in malnourished cancer patients: Revisiting an old dilemma. Clin Nutr 2024; 43:1320-1328. [PMID: 38669764 DOI: 10.1016/j.clnu.2024.03.018] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/28/2024] [Revised: 03/10/2024] [Accepted: 03/20/2024] [Indexed: 04/28/2024]
Abstract
BACKGROUND & AIMS GLIM definition of malnutrition is recognised all over the world and, when is referring to cancer, it specifies that weight or muscle loss are associated with an inflammatory status. However, the real-world practice shows that GLIM definition cannot encompass all the wide and heterogenous clinical presentations of cancer patients with malnutrition, which involves many other drivers beyond inflammation. Moreover, placing an excessive emphasis on the inflammation can overshadow, in the clinical practice, the role of the nutritional support in malnourished cancer patients. The aim of this paper is not to criticize the rationale of the GLIM definition of cancer cachexia, but to show the complexity and heterogeneity of malnutrition of cancer patients and reasons why nutritional support should deserve such a better consideration among the oncologists. METHODS Literature pertinent to pathophysiology of malnutrition of cancer patients is scrutinised and reasons for the frequent underuse of nutritional support are critically analysed. RESULTS The appraisal of the literature shows that there are various pathophysiological patterns of malnutrition among cancer patients and inflammatory markers are not universally present in weight-losing cancer patients. Inflammation alone does not account for weight loss in all cancer patients and factors other than inflammation can drive hypophagia and weight loss, and hypophagia appears to be a primary catalyst for weight loss. Furthermore, malnutrition may be the consequence of the presence of several Nutrition Impact Symptoms or of the oncologic therapy. The nutritional support may fail to show benefits in malnourished cancer patients because the golden standard to validate a therapy relies on RCT, but it is ethically impossible to have an unfed control group of malnourished patients. Furthermore, nutritional interventions often fell short of the optimal standards, adherence to treatment plans was often poor, nutritional support was mainly reserved for very advanced patients and the primary endpoints of the studies on nutritional support were sometimes unrealistic. CONCLUSION There is a gap between the suggestion of the guidelines which advocate the use of nutritional support to improve the compliance of patients facing intensive oncologic treatments or to prevent an early demise when patients enter a chronic phase of slow nutritional deterioration, and the poor use of nutrition in the real-world practice. This requires a higher level of awareness of the oncologists concerning the reasons for the lacking evidence of efficacy of the nutritional support and an understanding of its potential contribute to improve the outcome of the patients. Finally, this paper calls for a change of the oncologist's approach to the cancer patient, from only focusing on the cure of the tumour to taking care of the patient as a whole.
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11
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Brown LR, Sousa MS, Yule MS, Baracos VE, McMillan DC, Arends J, Balstad TR, Bye A, Dajani O, Dolan RD, Fallon MT, Greil C, Hjermstad MJ, Jakobsen G, Maddocks M, McDonald J, Ottestad IO, Phillips I, Sayers J, Simpson MR, Vagnildhaug OM, Solheim TS, Laird BJ, Skipworth RJ, the Cancer Cachexia Endpoints Working Group. Body weight and composition endpoints in cancer cachexia clinical trials: Systematic Review 4 of the cachexia endpoints series. J Cachexia Sarcopenia Muscle 2024; 15:816-852. [PMID: 38738581 PMCID: PMC11154800 DOI: 10.1002/jcsm.13478] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/29/2023] [Revised: 02/12/2024] [Accepted: 03/16/2024] [Indexed: 05/14/2024] Open
Abstract
Significant variation exists in the outcomes used in cancer cachexia trials, including measures of body composition, which are often selected as primary or secondary endpoints. To date, there has been no review of the most commonly selected measures or their potential sensitivity to detect changes resulting from the interventions being examined. The aim of this systematic review is to assess the frequency and diversity of body composition measures that have been used in cancer cachexia trials. MEDLINE, Embase and Cochrane Library databases were systematically searched between January 1990 and June 2021. Eligible trials examined adults (≥18 years) who had received an intervention aiming to treat or attenuate the effects of cancer cachexia for >14 days. Trials were also of a prospective controlled design and included body weight or at least one anthropometric, bioelectrical or radiological endpoint pertaining to body composition, irrespective of the modality of intervention (e.g., pharmacological, nutritional, physical exercise and behavioural) or comparator. Trials with a sample size of <40 patients were excluded. Data extraction used Covidence software, and reporting followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidance. This review was prospectively registered (PROSPERO: CRD42022276710). A total of 84 clinical trials, comprising 13 016 patients, were eligible for inclusion. Non-small-cell lung cancer and pancreatic cancer were studied most frequently. The majority of trial interventions were pharmacological (52%) or nutritional (34%) in nature. The most frequently reported endpoints were assessments of body weight (68 trials, n = 11 561) followed by bioimpedance analysis (BIA)-based estimates (23 trials, n = 3140). Sixteen trials (n = 3052) included dual-energy X-ray absorptiometry (DEXA)-based endpoints, and computed tomography (CT) body composition was included in eight trials (n = 841). Discrepancies were evident when comparing the efficacy of interventions using BIA-based estimates of lean tissue mass against radiological assessment modalities. Body weight, BIA and DEXA-based endpoints have been most frequently used in cancer cachexia trials. Although the optimal endpoints cannot be determined from this review, body weight, alongside measurements from radiological body composition analysis, would seem appropriate. The choice of radiological modality is likely to be dependent on the trial setting, population and intervention in question. CT and magnetic resonance imaging, which have the ability to accurately discriminate tissue types, are likely to be more sensitive and provide greater detail. Endpoints are of particular importance when aligned with the intervention's mechanism of action and/or intended patient benefit.
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Affiliation(s)
- Leo R. Brown
- Clinical SurgeryThe University of Edinburgh, Royal Infirmary of EdinburghEdinburghUK
| | - Mariana S. Sousa
- Improving Palliative, Aged and Chronic Care Through Clinical Research and Translation (IMPACCT)University of Technology SydneySydneyAustralia
| | - Michael S. Yule
- Clinical SurgeryThe University of Edinburgh, Royal Infirmary of EdinburghEdinburghUK
- Institute of Genetics and CancerThe University of Edinburgh, Western General HospitalEdinburghUK
- St Columba's Hospice CareEdinburghUK
| | | | - Donald C. McMillan
- Academic Unit of SurgeryUniversity of Glasgow, Glasgow Royal InfirmaryGlasgowUK
| | - Jann Arends
- Department of Medicine I, Medical Centre—University of Freiburg Faculty of MedicineUniversity of FreiburgFreiburgGermany
| | - Trude R. Balstad
- Department of Clinical and Molecular Medicine, Faculty of Medicine and Health SciencesNorwegian University of Science and TechnologyTrondheimNorway
- Department of Clinical Medicine, Clinical Nutrition Research GroupUiT The Arctic University of NorwayTromsøNorway
| | - Asta Bye
- Department of OncologyOslo University HospitalOsloNorway
- Department of Nursing and Health Promotion, Faculty of Health SciencesOslo Metropolitan UniversityOsloNorway
| | - Olav Dajani
- Department of OncologyOslo University HospitalOsloNorway
| | - Ross D. Dolan
- Academic Unit of SurgeryUniversity of Glasgow, Glasgow Royal InfirmaryGlasgowUK
| | - Marie T. Fallon
- Institute of Genetics and CancerThe University of Edinburgh, Western General HospitalEdinburghUK
- St Columba's Hospice CareEdinburghUK
| | - Christine Greil
- Department of Medicine I, Medical Centre—University of Freiburg Faculty of MedicineUniversity of FreiburgFreiburgGermany
| | | | - Gunnhild Jakobsen
- Department of Public Health and Nursing, Faculty of Medicine and Health SciencesNorwegian University of Science and TechnologyTrondheimNorway
- Cancer ClinicSt. Olav's Hospital, Trondheim University HospitalTrondheimNorway
| | - Matthew Maddocks
- Cicely Saunders Institute of Palliative Care, Policy and RehabilitationKing's College LondonLondonUK
| | - James McDonald
- Institute of Genetics and CancerThe University of Edinburgh, Western General HospitalEdinburghUK
- St Columba's Hospice CareEdinburghUK
| | - Inger O. Ottestad
- Department of Nutrition, Institute of Basic Medical SciencesUniversity of OsloOsloNorway
- The Clinical Nutrition Outpatient Clinic, Section of Clinical Nutrition, Department of Clinical Service, Division of Cancer MedicineOslo University HospitalOsloNorway
| | - Iain Phillips
- Edinburgh Cancer CentreWestern General HospitalEdinburghUK
| | - Judith Sayers
- Clinical SurgeryThe University of Edinburgh, Royal Infirmary of EdinburghEdinburghUK
- Institute of Genetics and CancerThe University of Edinburgh, Western General HospitalEdinburghUK
- St Columba's Hospice CareEdinburghUK
| | - Melanie R. Simpson
- Department of Nursing and Health Promotion, Faculty of Health SciencesOslo Metropolitan UniversityOsloNorway
| | - Ola M. Vagnildhaug
- Department of Clinical and Molecular Medicine, Faculty of Medicine and Health SciencesNorwegian University of Science and TechnologyTrondheimNorway
- Department of Public Health and Nursing, Faculty of Medicine and Health SciencesNorwegian University of Science and TechnologyTrondheimNorway
| | - Tora S. Solheim
- Department of Clinical and Molecular Medicine, Faculty of Medicine and Health SciencesNorwegian University of Science and TechnologyTrondheimNorway
- Department of Public Health and Nursing, Faculty of Medicine and Health SciencesNorwegian University of Science and TechnologyTrondheimNorway
| | - Barry J.A. Laird
- Institute of Genetics and CancerThe University of Edinburgh, Western General HospitalEdinburghUK
- St Columba's Hospice CareEdinburghUK
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12
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Løhre ET, Solheim TS, Jakobsen G, Vagnildhaug OM, Schmidberger Karlsen TL, Habberstad RH, Balstad TR, Thronæs M. Parenteral Nutrition in Palliative Cancer Care: Detrimental, Futile, or Beneficial? Curr Oncol 2024; 31:2748-2757. [PMID: 38785489 PMCID: PMC11120543 DOI: 10.3390/curroncol31050208] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/30/2024] [Revised: 05/07/2024] [Accepted: 05/09/2024] [Indexed: 05/25/2024] Open
Abstract
Palliative cancer care patients may live for a long time, but malnutrition worsens the prognosis. Parenteral nutrition (PN) is suitable for replenishing a calorie deficit, but its advantages and tolerance late in the cancer trajectory are debated. We examined symptom development in hospitalized patients with and without PN. A total of 21 palliative cancer care patients receiving PN and 155 palliative cancer care patients not receiving PN during hospitalization in a specialized unit were retrospectively compared. We studied symptom intensity at admission, symptom relief during the hospital stay, and survival. The patients had locally advanced or metastatic cancer, a mean age of 70 years, and their median ECOG performance status was III. Symptom burden at admission was similar in the compared groups. Symptom relief during hospitalization was also similar. However, patients already on PN at admission reported more nausea and patients receiving PN during hospitalization reported better nausea relief compared to patients not receiving this intervention. Overall median survival was less than two months and similar in the compared groups. Based on a limited number of observations and a suboptimal study design, we were not able to demonstrate an increased symptom burden for palliative cancer care patients receiving PN late in the disease trajectory.
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Affiliation(s)
- Erik Torbjørn Løhre
- Cancer Clinic, St. Olavs Hospital, Trondheim University Hospital, 7030 Trondheim, Norway
- Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, NTNU-Norwegian University of Science and Technology, 7030 Trondheim, Norway
- Centre for Crisis Psychology, Faculty of Psychology, University of Bergen, 5007 Bergen, Norway
| | - Tora Skeidsvoll Solheim
- Cancer Clinic, St. Olavs Hospital, Trondheim University Hospital, 7030 Trondheim, Norway
- Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, NTNU-Norwegian University of Science and Technology, 7030 Trondheim, Norway
| | - Gunnhild Jakobsen
- Cancer Clinic, St. Olavs Hospital, Trondheim University Hospital, 7030 Trondheim, Norway
- Department of Public Health and Nursing, Faculty of Medicine and Health Sciences, NTNU-Norwegian University of Science and Technology, 7030 Trondheim, Norway
| | - Ola Magne Vagnildhaug
- Cancer Clinic, St. Olavs Hospital, Trondheim University Hospital, 7030 Trondheim, Norway
- Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, NTNU-Norwegian University of Science and Technology, 7030 Trondheim, Norway
| | - Terese Louise Schmidberger Karlsen
- Cancer Clinic, St. Olavs Hospital, Trondheim University Hospital, 7030 Trondheim, Norway
- Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, NTNU-Norwegian University of Science and Technology, 7030 Trondheim, Norway
| | | | - Trude Rakel Balstad
- Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, NTNU-Norwegian University of Science and Technology, 7030 Trondheim, Norway
- Department of Clinical Medicine, Clinical Nutrition Research Group, UiT, The Arctic University of Norway, 9019 Tromsø, Norway
| | - Morten Thronæs
- Cancer Clinic, St. Olavs Hospital, Trondheim University Hospital, 7030 Trondheim, Norway
- Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, NTNU-Norwegian University of Science and Technology, 7030 Trondheim, Norway
- Centre for Crisis Psychology, Faculty of Psychology, University of Bergen, 5007 Bergen, Norway
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13
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Vagnildhaug OM, Balstad TR, Ottestad I, Bye A, Greil C, Arends J, Baracos V, Brown LR, Dajani OF, Dolan RD, Fallon M, Fraser E, Grzyb A, Hjermstad MJ, Jakobsen G, Kaasa S, McDonald J, Philips I, Sayers J, Simpson MR, Sousa MS, Skipworth RJ, Laird BJ, Solheim TS, the Cancer Cachexia Endpoints Working Group. Appetite and dietary intake endpoints in cancer cachexia clinical trials: Systematic Review 2 of the cachexia endpoints series. J Cachexia Sarcopenia Muscle 2024; 15:513-535. [PMID: 38343065 PMCID: PMC10995275 DOI: 10.1002/jcsm.13434] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/25/2023] [Revised: 12/21/2023] [Accepted: 12/27/2023] [Indexed: 04/06/2024] Open
Abstract
There is no consensus on the optimal endpoint(s) in cancer cachexia trials. Endpoint variation is an obstacle when comparing interventions and their clinical value. The aim of this systematic review was to summarize and evaluate endpoints used to assess appetite and dietary intake in cancer cachexia clinical trials. A search for studies published from 1 January 1990 until 2 June 2021 was conducted using MEDLINE, Embase and Cochrane Central Register of Controlled Trials. Eligible studies examined cancer cachexia treatment versus a comparator in adults with assessments of appetite and/or dietary intake as study endpoints, a sample size ≥40 and an intervention lasting ≥14 days. Reporting was in line with PRISMA guidance, and a protocol was published in PROSPERO (2022 CRD42022276710). This review is part of a series of systematic reviews examining cachexia endpoints. Of the 5975 articles identified, 116 were eligible for the wider review series and 80 specifically examined endpoints of appetite (65 studies) and/or dietary intake (21 studies). Six trials assessed both appetite and dietary intake. Appetite was the primary outcome in 15 trials and dietary intake in 7 trials. Median sample size was 101 patients (range 40-628). Forty-nine studies included multiple primary tumour sites, while 31 studies involved single primary tumour sites (15 gastrointestinal, 7 lung, 7 head and neck and 2 female reproductive organs). The most frequently reported appetite endpoints were visual analogue scale (VAS) and numerical rating scale (NRS) (40%). The appetite item from the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30/C15 PAL (38%) and the appetite question from North Central Cancer Treatment Group anorexia questionnaire (17%) were also frequently applied. Of the studies that assessed dietary intake, 13 (62%) used food records (prospective registrations) and 10 (48%) used retrospective methods (24-h recall or dietary history). For VAS/NRS, a mean change of 1.3 corresponded to Hedge's g of 0.5 and can be considered a moderate change. For food records, a mean change of 231 kcal/day or 11 g of protein/day corresponded to a moderate change. Choice of endpoint in cachexia trials will depend on factors pertinent to the trial to be conducted. Nevertheless, from trials assessed and available literature, NRS or EORTC QLQ C30/C15 PAL seems suitable for appetite assessments. Appetite and dietary intake endpoints are rarely used as primary outcomes in cancer cachexia. Dietary intake assessments were used mainly to monitor compliance and are not validated in cachexia populations. Given the importance to cachexia studies, dietary intake endpoints must be validated before they are used as endpoints in clinical trials.
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Affiliation(s)
- Ola Magne Vagnildhaug
- Department of Clinical and Molecular Medicine, Faculty of Medicine and Health SciencesNorwegian University of Science and Technology (NTNU)TrondheimNorway
- Cancer Clinic, St. Olavs HospitalTrondheim University HospitalTrondheimNorway
| | - Trude R. Balstad
- Department of Clinical and Molecular Medicine, Faculty of Medicine and Health SciencesNorwegian University of Science and Technology (NTNU)TrondheimNorway
- Department of Clinical Medicine, Clinical Nutrition Research GroupUiT The Arctic University of NorwayTromsøNorway
| | - Inger Ottestad
- Department of Nutrition, Institute of Basic Medical Sciences, Faculty of MedicineUniversity of OsloOsloNorway
- The Clinical Nutrition Outpatient Clinic, Section of Clinical Nutrition, Department of Clinical Service, Division of Cancer MedicineOslo University HospitalOsloNorway
| | - Asta Bye
- Regional Advisory Unit for Palliative Care, Department of Oncology, Oslo University HospitalUniversity of OsloOsloNorway
- European Palliative Care Research Centre (PRC), Department of Oncology, Oslo University Hospital and Institute of Clinical MedicineUniversity of OsloOsloNorway
- Department of Nursing and Health Promotion, Faculty of Health SciencesOsloMet—Oslo Metropolitan UniversityOsloNorway
| | - Christine Greil
- Department of Medicine I, Medical Center—University of Freiburg, Faculty of MedicineUniversity of FreiburgFreiburg im BreisgauGermany
| | - Jann Arends
- Department of Medicine I, Medical Center—University of Freiburg, Faculty of MedicineUniversity of FreiburgFreiburg im BreisgauGermany
| | - Vickie Baracos
- Department of OncologyUniversity of AlbertaEdmontonAlbertaCanada
| | - Leo R. Brown
- Clinical SurgeryUniversity of Edinburgh, Royal Infirmary of EdinburghEdinburghUK
| | - Olav F. Dajani
- Regional Advisory Unit for Palliative Care, Department of Oncology, Oslo University HospitalUniversity of OsloOsloNorway
- European Palliative Care Research Centre (PRC), Department of Oncology, Oslo University Hospital and Institute of Clinical MedicineUniversity of OsloOsloNorway
| | - Ross D. Dolan
- Academic Unit of SurgeryUniversity of Glasgow, Glasgow Royal InfirmaryGlasgowUK
| | - Marie Fallon
- Edinburgh Cancer Research CentreUniversity of EdinburghEdinburghUK
| | - Eilidh Fraser
- Edinburgh Cancer Research CentreUniversity of EdinburghEdinburghUK
| | - Aleksandra Grzyb
- Edinburgh Cancer Research CentreUniversity of EdinburghEdinburghUK
| | - Marianne J. Hjermstad
- Regional Advisory Unit for Palliative Care, Department of Oncology, Oslo University HospitalUniversity of OsloOsloNorway
- European Palliative Care Research Centre (PRC), Department of Oncology, Oslo University Hospital and Institute of Clinical MedicineUniversity of OsloOsloNorway
| | - Gunnhild Jakobsen
- Cancer Clinic, St. Olavs HospitalTrondheim University HospitalTrondheimNorway
- Department of Public Health and Nursing, Faculty of Medicine and Health SciencesNorwegian University of Science and Technology (NTNU)TrondheimNorway
| | - Stein Kaasa
- Regional Advisory Unit for Palliative Care, Department of Oncology, Oslo University HospitalUniversity of OsloOsloNorway
- European Palliative Care Research Centre (PRC), Department of Oncology, Oslo University Hospital and Institute of Clinical MedicineUniversity of OsloOsloNorway
| | - James McDonald
- Edinburgh Cancer Research CentreUniversity of EdinburghEdinburghUK
- Institute of Genetics and CancerUniversity of EdinburghEdinburghUK
| | - Iain Philips
- Edinburgh Cancer Research CentreUniversity of EdinburghEdinburghUK
| | - Judith Sayers
- Edinburgh Cancer Research CentreUniversity of EdinburghEdinburghUK
- Institute of Genetics and CancerUniversity of EdinburghEdinburghUK
- St Columba's HospiceEdinburghUK
| | - Melanie R. Simpson
- Department of Public Health and Nursing, Faculty of Medicine and Health SciencesNorwegian University of Science and Technology (NTNU)TrondheimNorway
| | - Mariana S. Sousa
- Improving Palliative, Aged and Chronic Care through Clinical Research and Translation (IMPACCT)University of Technology SydneySydneyNew South WalesAustralia
| | | | - Barry J.A. Laird
- Edinburgh Cancer Research CentreUniversity of EdinburghEdinburghUK
- Institute of Genetics and CancerUniversity of EdinburghEdinburghUK
- St Columba's HospiceEdinburghUK
| | - Tora S. Solheim
- Department of Clinical and Molecular Medicine, Faculty of Medicine and Health SciencesNorwegian University of Science and Technology (NTNU)TrondheimNorway
- Cancer Clinic, St. Olavs HospitalTrondheim University HospitalTrondheimNorway
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14
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Bischoff SC, Arends J, Decker-Baumann C, Hütterer E, Koch S, Mühlebach S, Roetzer I, Schneider A, Seipt C, Simanek R, Stanga Z. S3-Leitlinie Heimenterale und heimparenterale Ernährung der Deutschen
Gesellschaft für Ernährungsmedizin (DGEM). AKTUELLE ERNÄHRUNGSMEDIZIN 2024; 49:73-155. [DOI: 10.1055/a-2270-7667] [Citation(s) in RCA: 1] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 01/05/2025]
Abstract
ZusammenfassungMedizinische Ernährungstherapie, die enterale und parenterale Ernährung umfasst,
ist ein wesentlicher Teil der Ernährungstherapie. Medizinische
Ernährungstherapie beschränkt sich nicht auf die Krankenhausbehandlung, sondern
kann effektiv und sicher auch zu Hause eingesetzt werden. Dadurch hat sich der
Stellenwert der Medizinischen Ernährungstherapie deutlich erhöht und ist zu
einem wichtigen Bestandteil der Therapie vieler chronischer Erkrankungen
geworden. Für Menschen mit chronischem Darmversagen, z. B. wegen Kurzdarmsyndrom
ist die Medizinische Ernährungstherapie sogar lebensrettend. In der Leitlinie
wird die Evidenz für die Medizinische Ernährungstherapie in 161 Empfehlungen
dargestellt. Die Leitlinie wendet sich in erster Linie an Ärzte,
Ernährungsfachkräfte und Pflegekräfte, sie dient der Information für
Pharmazeuten und anderes Fachpersonal, kann aber auch für den interessierten
Laien hilfreich sein.
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Affiliation(s)
- Stephan C. Bischoff
- Institut für Ernährungsmedizin, Universität Hohenheim, Stuttgart,
Deutschland
| | - Jann Arends
- Klinik für Innere Medizin I, Universitätsklinikum Freiburg,
Medizinische Fakultät, Albert-Ludwigs-Universität Freiburg,
Deutschland
| | - Christiane Decker-Baumann
- Nationales Centrum für Tumorerkrankungen (NCT), Universitätsklinikum
Heidelberg, Heidelberg, Deutschland
| | - Elisabeth Hütterer
- Medizinische Universität Wien, Universitätsklinik für Innere Medizin I,
Wien, Österreich
| | - Sebastian Koch
- Medizinische Klinik mit Schwerpunkt Infektiologie und Pneumologie
Campus Charité Mitte, Charité Universitätsmedizin Berlin, Berlin,
Deutschland
| | - Stefan Mühlebach
- Universität Basel, Institut für Klinische Pharmazie & Epidemiologe,
Spitalpharmazie, Basel, Schweiz
| | - Ingeborg Roetzer
- Nationales Centrum für Tumorerkrankungen (NCT), Universitätsklinikum
Heidelberg, Heidelberg, Deutschland
- Klinik für Hämatologie und Onkologie, Krankenhaus Nordwest, Frankfurt
am Main, Deutschland
| | - Andrea Schneider
- Medizinische Hochschule Hannover, Klinik für Gastroenterologie,
Hepatologie, Infektiologie und Endokrinologie, Hannover,
Deutschland
| | - Claudia Seipt
- Medizinische Hochschule Hannover, Klinik für Gastroenterologie,
Hepatologie, Infektiologie und Endokrinologie, Hannover,
Deutschland
| | - Ralph Simanek
- Gesundheitszentrum Floridsdorf der Österreichischen Gesundheitskasse,
Hämatologische Ambulanz, Wien, Österreich
| | - Zeno Stanga
- Universitätsklinik für Diabetologie, Endokrinologie, Ernährungsmedizin
und Metabolismus, Inselspital, Universitätsspital Bern und Universität Bern,
Bern, Schweiz
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15
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Fernández-Argüeso M, Gómez-Bayona E, Ugalde B, Vega-Piñero B, Gil-Díaz M, Longo F, Pintor R, Botella-Carretero JI. Ready-to-Use Multichamber Bags in Home Parenteral Nutrition for Patients with Advanced Cancer: A Single-Center Prospective Study. Nutrients 2024; 16:457. [PMID: 38337741 PMCID: PMC10856902 DOI: 10.3390/nu16030457] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/11/2024] [Revised: 01/28/2024] [Accepted: 02/03/2024] [Indexed: 02/12/2024] Open
Abstract
Home parenteral nutrition (HPN) is increasingly prescribed for patients with advanced cancer. This therapy improves free-fat mass, quality of life and survival, but it is not free from complications, especially catheter-related bloodstream infections (CRBSIs). The use of commercial multichamber bags in HPN has not been extensively explored in oncologic patients and their association with complications is not well known. In this prospective cohort study, we included 130 patients with advanced cancer and HPN. We compared the effects of individual compounded bags (n = 87) vs. commercial multichamber bags (n = 43) on complications. There were no differences in any complication, including thrombosis (p > 0.05). There were 0.28 episodes of CRBSI per 1000 catheter days in the individual compounded bag group and 0.21 in the multichamber bag group (p > 0.05). A total of 34 patients were weaned off HPN, 22 with individual bags and 12 with multichamber bags (p = 0.749). Regarding survival when on HPN, the group with individual bags showed a median of 98 days (95% CI of 49-147), whereas those with multichamber bags showed a median of 88 days (95% CI of 43-133 (p = 0.913)). In conclusion, commercial multichamber bags for HPN in patients with advanced cancer are non-inferior when compared to individual compounded bags in terms of complications.
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Affiliation(s)
- María Fernández-Argüeso
- Department of Endocrinology and Nutrition, Hospital Universitario Ramón y Cajal, 28034 Madrid, Spain; (M.F.-A.); (B.U.); (B.V.-P.); (M.G.-D.)
| | - Elena Gómez-Bayona
- Department of Pharmacy, Hospital Universitario Ramón y Cajal, 28034 Madrid, Spain; (E.G.-B.); (R.P.)
| | - Beatriz Ugalde
- Department of Endocrinology and Nutrition, Hospital Universitario Ramón y Cajal, 28034 Madrid, Spain; (M.F.-A.); (B.U.); (B.V.-P.); (M.G.-D.)
- IRyCIS—Instituto Ramón y Cajal de Investigación Sanitaria, Hospital Universitario Ramón y Cajal, 28034 Madrid, Spain
| | - Belén Vega-Piñero
- Department of Endocrinology and Nutrition, Hospital Universitario Ramón y Cajal, 28034 Madrid, Spain; (M.F.-A.); (B.U.); (B.V.-P.); (M.G.-D.)
- IRyCIS—Instituto Ramón y Cajal de Investigación Sanitaria, Hospital Universitario Ramón y Cajal, 28034 Madrid, Spain
| | - Mayra Gil-Díaz
- Department of Endocrinology and Nutrition, Hospital Universitario Ramón y Cajal, 28034 Madrid, Spain; (M.F.-A.); (B.U.); (B.V.-P.); (M.G.-D.)
| | - Federico Longo
- Department of Clinical Oncology, Hospital Universitario Ramón y Cajal, 28034 Madrid, Spain;
| | - Rosario Pintor
- Department of Pharmacy, Hospital Universitario Ramón y Cajal, 28034 Madrid, Spain; (E.G.-B.); (R.P.)
| | - José I. Botella-Carretero
- Department of Endocrinology and Nutrition, Hospital Universitario Ramón y Cajal, 28034 Madrid, Spain; (M.F.-A.); (B.U.); (B.V.-P.); (M.G.-D.)
- IRyCIS—Instituto Ramón y Cajal de Investigación Sanitaria, Hospital Universitario Ramón y Cajal, 28034 Madrid, Spain
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16
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Cotogni P, Shaw C, Jimenez-Fonseca P, Partridge D, Pritchett D, Webb N, Crompton A, Garcia-Lorda P, Shepelev J. High-protein home parenteral nutrition in malnourished oncology patients: a systematic literature review. Support Care Cancer 2023; 32:52. [PMID: 38129578 PMCID: PMC10739567 DOI: 10.1007/s00520-023-08218-z] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/30/2023] [Accepted: 11/30/2023] [Indexed: 12/23/2023]
Abstract
INTRODUCTION Up to 83% of oncology patients are affected by cancer-related malnutrition, depending on tumour location and patient age. Parenteral nutrition can be used to manage malnutrition, but there is no clear consensus as to the optimal protein dosage. The objective of this systematic literature review (SLR) was to identify studies on malnourished oncology patients receiving home parenteral nutrition (HPN) where protein or amino acid delivery was reported in g/kg bodyweight/day, and to compare outcomes between patients receiving low (< 1 g/kg bodyweight/day), standard (1-1.5 g/kg/day), and high-protein doses (> 1.5 g/kg/day). METHODS Literature searches were performed on 5th October 2021 in Embase, MEDLINE, and five Cochrane Library and Centre for Reviews and Dissemination databases. Searches were complemented by hand-searching of conference proceedings, a clinical trial registry, and bibliographic reference lists of included studies and relevant SLRs/meta-analyses. RESULTS Nineteen publications were included; sixteen investigated standard protein, two reported low protein, and one included both, but none assessed high-protein doses. Only one randomised controlled trial (RCT) was identified; all other studies were observational studies. The only study to compare two protein doses reported significantly greater weight gain in patients receiving 1.15 g/kg/day than those receiving 0.77 g/kg/day. CONCLUSION At present, there is insufficient evidence to determine the optimal protein dosage for malnourished oncology patients receiving HPN. Data from non-HPN studies and critically ill patients indicate that high-protein interventions are associated with increased overall survival and quality of life; further studies are needed to establish whether the same applies in malnourished oncology patients.
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Affiliation(s)
- Paolo Cotogni
- Pain Management and Palliative Care, Department of Anesthesia, Intensive Care and Emergency, Molinette Hospital and University of Turin, Turin, Italy.
| | - Clare Shaw
- Biomedical Research Centre at The Royal Marsden and Institute of Cancer Research, London and Sutton, UK
| | | | | | | | | | | | | | - Julian Shepelev
- Worldwide Medical, Health Economics and Outcomes Research, Baxter Healthcare SA, Zurich, Switzerland
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17
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McDonald J, Sayers J, Anker SD, Arends J, Balstad TR, Baracos V, Brown L, Bye A, Dajani O, Dolan R, Fallon MT, Fraser E, Griel C, Grzyb A, Hjermstad M, Jamal‐Hanjani M, Jakobsen G, Kaasa S, McMillan D, Maddocks M, Philips I, Ottestad IO, Reid KF, Sousa MS, Simpson MR, Vagnildhaug OM, Skipworth RJE, Solheim TS, Laird BJA, the Cancer Cachexia Endpoints Working Group. Physical function endpoints in cancer cachexia clinical trials: Systematic Review 1 of the cachexia endpoints series. J Cachexia Sarcopenia Muscle 2023; 14:1932-1948. [PMID: 37671529 PMCID: PMC10570071 DOI: 10.1002/jcsm.13321] [Citation(s) in RCA: 24] [Impact Index Per Article: 12.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/05/2023] [Revised: 06/19/2023] [Accepted: 08/02/2023] [Indexed: 09/07/2023] Open
Abstract
In cancer cachexia trials, measures of physical function are commonly used as endpoints. For drug trials to obtain regulatory approval, efficacy in physical function endpoints may be needed alongside other measures. However, it is not clear which physical function endpoints should be used. The aim of this systematic review was to assess the frequency and diversity of physical function endpoints in cancer cachexia trials. Following a comprehensive electronic literature search of MEDLINE, Embase and Cochrane (1990-2021), records were retrieved. Eligible trials met the following criteria: adults (≥18 years), controlled design, more than 40 participants, use of a cachexia intervention for more than 14 days and use of a physical function endpoint. Physical function measures were classified as an objective measure (hand grip strength [HGS], stair climb power [SCP], timed up and go [TUG] test, 6-min walking test [6MWT] and short physical performance battery [SPPB]), clinician assessment of function (Karnofsky Performance Status [KPS] or Eastern Cooperative Oncology Group-Performance Status [ECOG-PS]) or patient-reported outcomes (physical function subscale of the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaires [EORTC QLQ-C30 or C15]). Data extraction was performed using Covidence and followed PRISMA guidance (PROSPERO registration: CRD42022276710). A total of 5975 potential studies were examined and 71 were eligible. Pharmacological interventions were assessed in 38 trials (54%). Of these, 11 (29%, n = 1184) examined megestrol and 5 (13%, n = 1928) examined anamorelin; nutritional interventions were assessed in 21 trials (30%); and exercise-based interventions were assessed in 6 trials (8%). The remaining six trials (8%) assessed multimodal interventions. Among the objective measures of physical function (assessed as primary or secondary endpoints), HGS was most commonly examined (33 trials, n = 5081) and demonstrated a statistically significant finding in 12 (36%) trials (n = 2091). The 6MWT was assessed in 12 trials (n = 1074) and was statistically significant in 4 (33%) trials (n = 403), whereas SCP, TUG and SPPB were each assessed in 3 trials. KPS was more commonly assessed than the newer ECOG-PS (16 vs. 9 trials), and patient-reported EORTC QLQ-C30 physical function was reported in 25 trials. HGS is the most commonly used physical function endpoint in cancer cachexia clinical trials. However, heterogeneity in study design, populations, intervention and endpoint selection make it difficult to comment on the optimal endpoint and how to measure this. We offer several recommendations/considerations to improve the design of future clinical trials in cancer cachexia.
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Affiliation(s)
- James McDonald
- Edinburgh Cancer Research CentreUniversity of EdinburghEdinburghUK
- St Columba's HospiceEdinburghUK
| | - Judith Sayers
- Edinburgh Cancer Research CentreUniversity of EdinburghEdinburghUK
- St Columba's HospiceEdinburghUK
- Clinical SurgeryUniversity of Edinburgh, Royal Infirmary of EdinburghEdinburghUK
| | - Stefan D. Anker
- Department of Cardiology (CVK), Berlin Institute of Health Center for Regenerative Therapies (BCRT), and German Centre for Cardiovascular Research (DZHK) partner site BerlinCharité UniversitätsmedizinBerlinGermany
- Institute of Heart DiseasesWroclaw Medical UniversityWroclawPoland
- German Centre for Cardiovascular Research (DZHK) partner site BerlinCharité Universitätsmedizin BerlinBerlinGermany
| | - Jann Arends
- Department of Medicine I, Medical Center – University of Freiburg, Faculty of MedicineUniversity of FreiburgFreiburg im BreisgauGermany
| | - Trude Rakel Balstad
- Department of Clinical and Molecular Medicine, Faculty of Medicine and Health SciencesNTNU–Norwegian University of Science and TechnologyTrondheimNorway
- Department of Clinical Medicine, Clinical Nutrition Research GroupUiT The Arctic University of NorwayTromsøNorway
| | - Vickie Baracos
- Division of Palliative Care Medicine, Department of OncologyUniversity of AlbertaEdmontonABCanada
| | - Leo Brown
- Clinical SurgeryUniversity of Edinburgh, Royal Infirmary of EdinburghEdinburghUK
| | - Asta Bye
- Regional Advisory Unit for Palliative Care, Department of Oncology, Oslo University Hospital/European Palliative Care Research Centre (PRC), and Institute of Clinical MedicineUniversity of OsloOsloNorway
- Department of Nursing and Health Promotion, Faculty of Health SciencesOslo Metropolitan UniversityOsloNorway
| | - Olav Dajani
- Regional Advisory Unit for Palliative Care, Department of Oncology, Oslo University Hospital/European Palliative Care Research Centre (PRC), and Institute of Clinical MedicineUniversity of OsloOsloNorway
| | - Ross Dolan
- Academic Unit of SurgeryUniversity of Glasgow, Glasgow Royal InfirmaryGlasgowUK
| | - Marie T. Fallon
- Edinburgh Cancer Research CentreUniversity of EdinburghEdinburghUK
| | - Eilidh Fraser
- Edinburgh Cancer Research CentreUniversity of EdinburghEdinburghUK
| | - Christine Griel
- Department of Medicine I, Medical Center – University of Freiburg, Faculty of MedicineUniversity of FreiburgFreiburg im BreisgauGermany
| | - Aleksandra Grzyb
- Edinburgh Cancer Research CentreUniversity of EdinburghEdinburghUK
| | - Marianne Hjermstad
- Regional Advisory Unit for Palliative Care, Department of Oncology, Oslo University Hospital/European Palliative Care Research Centre (PRC), and Institute of Clinical MedicineUniversity of OsloOsloNorway
| | - Mariam Jamal‐Hanjani
- Cancer Research UK Lung Cancer Centre of ExcellenceUniversity College London Cancer InstituteLondonUK
- Cancer Metastasis LaboratoryUniversity College London Cancer InstituteLondonUK
- Department of OncologyUniversity College London HospitalsLondonUK
| | - Gunnhild Jakobsen
- Department of Public Health and NursingNorwegian University of Science and TechnologyTrondheimNorway
| | - Stein Kaasa
- Regional Advisory Unit for Palliative Care, Department of Oncology, Oslo University Hospital/European Palliative Care Research Centre (PRC), and Institute of Clinical MedicineUniversity of OsloOsloNorway
| | - Donald McMillan
- Academic Unit of SurgeryUniversity of Glasgow, Glasgow Royal InfirmaryGlasgowUK
| | - Matthew Maddocks
- Cicely Saunders Institute of Palliative Care, Policy and RehabilitationKing's College LondonLondonUK
| | - Iain Philips
- Edinburgh Cancer Research CentreUniversity of EdinburghEdinburghUK
| | - Inger O. Ottestad
- Department of Nutrition, Institute of Basic Medical Sciences, Faculty of Medicine, University of Oslo, Norway and The Clinical Nutrition Outpatient Clinic, Section of Clinical Nutrition, Department of Clinical Service, Division of Cancer MedicineHarvard Medical SchoolOslo University HospitalNorway
| | - Kieran F. Reid
- Laboratory of Exercise Physiology and Physical Performance, Boston Claude D. Pepper Older Americans Independence Center for Function Promoting Therapies, Brigham and Women's HospitalHarvard Medical SchoolBostonMAUSA
| | - Mariana S. Sousa
- Improving Palliative, Aged and Chronic Care through Clinical Research and Translation (IMPACCT)University of Technology SydneySydneyNSWAustralia
| | - Melanie R. Simpson
- Department of Public Health and NursingNorwegian University of Science and TechnologyTrondheimNorway
| | - Ola Magne Vagnildhaug
- Cancer ClinicSt Olavs Hospital – Trondheim University HospitalTrondheimNorway
- Department of Clinical and Molecular MedicineNorwegian University of Science and TechnologyTrondheimNorway
| | | | - Tora S. Solheim
- Cancer ClinicSt Olavs Hospital – Trondheim University HospitalTrondheimNorway
- Department of Clinical and Molecular MedicineNorwegian University of Science and TechnologyTrondheimNorway
| | - Barry J. A. Laird
- Edinburgh Cancer Research CentreUniversity of EdinburghEdinburghUK
- St Columba's HospiceEdinburghUK
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18
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Clement DSVM, Brown SE, Naghibi M, Cooper SC, Tesselaar MET, van Leerdam ME, Ramage JK, Srirajaskanthan R. Feasibility of Home Parenteral Nutrition in Patients with Intestinal Failure Due to Neuroendocrine Tumours: A Systematic Review. Nutrients 2023; 15:3787. [PMID: 37686819 PMCID: PMC10490066 DOI: 10.3390/nu15173787] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/09/2023] [Revised: 08/23/2023] [Accepted: 08/24/2023] [Indexed: 09/10/2023] Open
Abstract
INTRODUCTION Maintaining adequate nutritional status can be a challenge for patients with small bowel neuroendocrine tumours (NETs). Surgical resection could result in short bowel syndrome (SBS), whilst without surgical resection there is a considerable risk of ischemia or developing an inoperable malignant bowel obstruction (IMBO). SBS or IMBO are forms of intestinal failure (IF) which might require treatment with home parenteral nutrition (HPN). Limited data exist regarding the use of HPN in patients with small bowel neuroendocrine tumours, and it is not frequently considered as a possible treatment. METHODS A systematic review was performed regarding patients with small bowel NETs and IF to report on overall survival and HPN-related complications and create awareness for this treatment. RESULTS Five articles regarding patients with small bowel NETs or a subgroup of patients with NETs could be identified, mainly case series with major concerns regarding bias. The studies included 60 patients (range 1-41). The overall survival time varied between 0.5 and 154 months on HPN. However, 58% of patients were alive 1 year after commencing HPN. The reported catheter-related bloodstream infection rate was 0.64-2 per 1000 catheter days. CONCLUSION This systematic review demonstrates the feasibility of the use of HPN in patients with NETs and IF in expert centres with a reasonable 1-year survival rate and low complication rate. Further research is necessary to compare patients with NETs and IF with and without HPN and the effect of HPN on their quality of life.
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Affiliation(s)
- Dominique S. V. M. Clement
- Kings Health Partners, ENETS Centre of Excellence, Institute of Liver Studies, King’s College Hospital, London SE5 9RS, UK
- Department of Gastroenterology, King’s College Hospital, London SE5 9RS, UK
| | - Sarah E. Brown
- Kings Health Partners, ENETS Centre of Excellence, Institute of Liver Studies, King’s College Hospital, London SE5 9RS, UK
- Department of Gastroenterology, King’s College Hospital, London SE5 9RS, UK
| | - Mani Naghibi
- Intestinal Rehabilitation Unit, St Mark’s and Northwick Park Hospitals, London HA1 3UJ, UK
| | - Sheldon C. Cooper
- Department of Gastroenterology, University Hospital Birmingham, Birmingham B75 7RR, UK
| | - Margot E. T. Tesselaar
- Department of Gastrointestinal Oncology, Netherlands Cancer Institute, ENETS Centre of Excellence, 1066 CX Amsterdam, The Netherlands
| | - Monique E. van Leerdam
- Department of Gastrointestinal Oncology, Netherlands Cancer Institute, ENETS Centre of Excellence, 1066 CX Amsterdam, The Netherlands
- Department of Gastroenterology and Hepatology, Leiden University Medical Center, 2333 ZA Leiden, The Netherlands
| | - John K. Ramage
- Kings Health Partners, ENETS Centre of Excellence, Institute of Liver Studies, King’s College Hospital, London SE5 9RS, UK
| | - Rajaventhan Srirajaskanthan
- Kings Health Partners, ENETS Centre of Excellence, Institute of Liver Studies, King’s College Hospital, London SE5 9RS, UK
- Department of Gastroenterology, King’s College Hospital, London SE5 9RS, UK
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19
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Pironi L, Boeykens K, Bozzetti F, Joly F, Klek S, Lal S, Lichota M, Mühlebach S, Van Gossum A, Wanten G, Wheatley C, Bischoff SC. ESPEN practical guideline: Home parenteral nutrition. Clin Nutr 2023; 42:411-430. [PMID: 36796121 DOI: 10.1016/j.clnu.2022.12.003] [Citation(s) in RCA: 26] [Impact Index Per Article: 13.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/29/2022] [Accepted: 12/05/2022] [Indexed: 01/11/2023]
Abstract
This guideline will inform physicians, nurses, dieticians, pharmacists, caregivers and other home parenteral nutrition (HPN) providers, as well as healthcare administrators and policy makers, about appropriate and safe HPN provision. This guideline will also inform patients requiring HPN. The guideline is based on previous published guidelines and provides an update of current evidence and expert opinion; it consists of 71 recommendations that address the indications for HPN, central venous access device (CVAD) and infusion pump, infusion catheter and CVAD site care, nutritional admixtures, program monitoring and management. Meta-analyses, systematic reviews and single clinical trials based on clinical questions were searched according to the PICO format. The evidence was evaluated and used to develop clinical recommendations implementing Scottish Intercollegiate Guidelines Network methodology. The guideline was commissioned and financially supported by ESPEN and members of the guideline group were selected by ESPEN.
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Affiliation(s)
- Loris Pironi
- University of Bologna, Department of Medical and Surgical Sciences, Italy; IRCCS AOUBO, Centre for Chronic Intestinal Failure - Clinical Nutrition and Metabolism Unit, Italy.
| | - Kurt Boeykens
- Vitaz Hospital, Nutrition Support Team, Sint-Niklaas, Belgium
| | | | - Francisca Joly
- Beaujon Hospital, APHP, University of Paris VII, Clichy, France
| | - Stanislaw Klek
- Surgical Oncology Clinic, The Maria Sklodowska-Curie National Cancer Institute, Krakow, Poland
| | - Simon Lal
- Salford Royal NHS Foundation Trust, Salford, UK
| | - Marek Lichota
- Intestinal Failure Patients Association "Appetite for Life", Cracow, Poland
| | - Stefan Mühlebach
- Division of Clinical Pharmacy and Epidemiology and Hospital Pharmacy, University of Basel, Basel, Switzerland
| | | | - Geert Wanten
- Intestinal Failure Unit, Radboud University Medical Centre, Nijmegen, the Netherlands
| | - Carolyn Wheatley
- Support and Advocacy Group for People on Home Artificial Nutrition (PINNT), UK
| | - Stephan C Bischoff
- University of Hohenheim, Institute of Nutritional Medicine, Stuttgart, Germany
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20
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Follow-up of Patients Receiving Home Parenteral Nutrition With a Competent Home Infusion Nurse Decreases the Prevalence of Catheter Infections. TOP CLIN NUTR 2023. [DOI: 10.1097/tin.0000000000000306] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/24/2022]
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21
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Smith LO, Olieman JF, Berk KA, Ligthart-Melis GC, Earthman CP. Clinical applications of body composition and functional status tools for nutrition assessment of hospitalized adults: A systematic review. JPEN J Parenter Enteral Nutr 2023; 47:11-29. [PMID: 36036239 DOI: 10.1002/jpen.2444] [Citation(s) in RCA: 9] [Impact Index Per Article: 4.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/31/2022] [Revised: 08/16/2022] [Accepted: 08/22/2022] [Indexed: 01/11/2023]
Abstract
BACKGROUND No global consensus exists on diagnostic criteria for malnutrition. Muscular deficits and functional impairments are major components of available malnutrition diagnostic frameworks because these facets of nutrition status significantly impact outcomes. The purpose of this review is to explore which body composition assessment (BCA) and functional status assessment (FSA) tools are being used for nutrition assessment (NA) and monitoring the response to nutrition interventions (RNIs) in adult inpatients. METHODS A literature search of Embase, Medline (Ovid), Web of Science, and Cochrane Central was performed to identify studies that used BCA and/or FSA tools for NA (along with an accepted NA diagnostic framework) and/or for monitoring RNI in adult inpatients. RESULTS The search yielded 3667 articles; 94 were included in the review. The number of studies using BCA and/or FSA tools for NA was 47 and also 47 for monitoring RNI. Seventy-nine percent of studies used bioimpedance for BCA, and 97% that included FSA utilized handgrip strength. When compared against sets of diagnostic criteria, many of the BCA and FSA tools showed promising associations with nutrition status. CONCLUSION Bioimpedance methods are the most widely used bedside BCA tools, and handgrip strength is the most widely used FSA tool; however, these methods are being used with a variety of protocols, algorithms, and interpretation practices in heterogeneous populations. To create a standardized nutrition status assessment process there is a need for validation studies on bedside methods and the development of globally standardized assessment protocols in clinical inpatient settings.
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Affiliation(s)
- Luke O Smith
- Department of Behavioral Health and Nutrition, University of Delaware, Newark, Delaware, USA
| | - Joanne F Olieman
- Division of Dietetics, Department of Internal Medicine, Erasmus Medical Center, Rotterdam, the Netherlands
| | - Kirsten A Berk
- Division of Dietetics, Department of Internal Medicine, Erasmus Medical Center, Rotterdam, the Netherlands
| | - Gerdien C Ligthart-Melis
- Division of Dietetics, Department of Internal Medicine, Erasmus Medical Center, Rotterdam, the Netherlands
| | - Carrie P Earthman
- Department of Behavioral Health and Nutrition, University of Delaware, Newark, Delaware, USA
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22
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Cotogni P, Bozzetti F, Goldwasser F, Jimenez-Fonseca P, Roelsgaard Obling S, Valle JW. Supplemental parenteral nutrition in cancer care: why, who, when. Ther Adv Med Oncol 2022; 14:17588359221113691. [PMID: 36188487 PMCID: PMC9520136 DOI: 10.1177/17588359221113691] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/16/2022] [Accepted: 06/28/2022] [Indexed: 11/15/2022] Open
Abstract
Malnutrition is an often-overlooked challenge for patients with cancer. It is associated with muscle mass reduction, poor compliance and response to cancer treatments, decreased quality of life, and reduced survival time. The nutritional assessment and intervention should be a vital part of any comprehensive cancer treatment plan. However, data on artificial nutrition supplied based on caloric needs during cancer care are scarce. In this review, we discuss the recommendations of the European and American societies for clinical nutrition on the use of nutritional interventions in malnourished patients with cancer in the context of current clinical practice. In particular, when enteral nutrition (oral or tube feeding) is not feasible or fails to meet the complete nutritional needs, supplemental parenteral nutrition (SPN) can bridge the gap. We report the available evidence on SPN in cancer patients and identify the perceived barriers to the wider application of this intervention. Finally, we suggest a ‘permissive’ role of SPN in cancer care but highlight the need for rigorous clinical studies to further evaluate the use of SPN in different populations of cancer patients.
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Affiliation(s)
- Paolo Cotogni
- Pain Management and Palliative Care, Department of Anesthesia, Intensive Care and Emergency, Molinette Hospital, University of Turin, Corso Bramante 88-90, Turin 10126, Italy
| | | | - François Goldwasser
- Medical Oncology Department, URP 4466, Cochin Hospital, AP-HP, Paris University, Paris, France
| | - Paula Jimenez-Fonseca
- Medical Oncology Department, Asturias Central University Hospital, ISPA, Oviedo, Spain
| | - Sine Roelsgaard Obling
- Department of Medical Gastroenterology, Odense University Hospital, University of Southern Denmark, Odense, Denmark
| | - Juan W Valle
- Division of Cancer Sciences, The University of Manchester, Manchester, UK.,Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester, UK
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23
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Li W, Guo H, Li L, Cui J. Cost-Effectiveness Analyses of Home Parenteral Nutrition for Incurable Gastrointestinal Cancer Patients. Front Oncol 2022; 12:858712. [PMID: 35664760 PMCID: PMC9157576 DOI: 10.3389/fonc.2022.858712] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/20/2022] [Accepted: 04/13/2022] [Indexed: 11/18/2022] Open
Abstract
Background Appropriate nutritional support, including supplemental home parenteral nutrition (sHPN), may improve prognosis and quality of life (Qol) of malnourished cancer patients. We aimed to explore the cost-effectiveness of sHPN for incurable gastrointestinal cancer patients from the Chinese healthcare perspective. Method Clinical data were extracted from a randomized controlled trial (NCT02066363). Patients were randomized into the sHPN group or the non-sHPN group (receiving best practice nutritional care). A Markov model was established with a 6-week cycle length. Costs were acquired from local hospitals, effect parameters included quality-adjusted life year (QALY), Qol, body mass index, fat-free mass (FFM), FFM index, handgrip strength, and a 6-min walking test. Sensitivity analyses were conducted with a willingness-to-pay (WTP) set at 3 per capita gross domestic product ($29,307/QALY). Results When considering QALY as a utility, the incremental cost-effectiveness ratio (ICER) was $24,289.17, with an incremental cost of $2,051.18 and an incremental QALY of 0.0844 between the sHPN group and the non-sHPN group. Furthermore, we explored the cost-effectiveness of sHPN from multidimensions, where we analyzed various effect parameters at different visits; the results showed a superior benefit for patients in the sHPN group except for the handgrip parameter at visit 2. Sensitivity analysis demonstrated the influence of utilities in the sHPN group, but the sHPN group was still cost-effective with a WTP of $2,500/QALY. Conclusion In China, sHPN was cost-effective for patients with incurable gastrointestinal cancer, which suggested further applications in clinical practice and provided references for clinical decisions and pricing.
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Affiliation(s)
| | | | | | - Jiuwei Cui
- Cancer Center, The First Hospital of Jilin University, Changchun, China
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24
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Gastrointestinal Cancer Patient Nutritional Management: From Specific Needs to Novel Epigenetic Dietary Approaches. Nutrients 2022; 14:nu14081542. [PMID: 35458104 PMCID: PMC9024975 DOI: 10.3390/nu14081542] [Citation(s) in RCA: 15] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/28/2022] [Revised: 03/28/2022] [Accepted: 04/05/2022] [Indexed: 02/06/2023] Open
Abstract
Nutritional habits impinge on the health of the gastrointestinal (GI) tract, contributing to GI disorder progression. GI cancer is a widespread and aggressive tumor sensitive to nutritional changes. Indeed, specific nutritional expedients can be adopted to prevent GI cancer onset and to slow down disease activity. Moreover, the patient’s nutritional status impacts prognosis, quality of life, and chemotherapy tolerance. These patients encounter the highest frequency of malnourishment risk, a condition that can progressively evolve into cachexia. Clinical studies dealing with this topic stressed the importance of nutritional counseling and put under the spotlight nutrient delivery, the type of nutrient supplementation, and timing for the start of nutritional management. A medical practitioner well-prepared on the topic of nutrition and cancer should operate in the clinical team dedicated to these oncological patients. This specific expertise needs to be implemented as soon as possible to adopt nutritional interventions and establish a proper patient-tailored dietary regimen. The nutritional gap closure should be prompt during anticancer treatment to stabilize weight loss, improve treatment tolerability, and ameliorate survival rate. Recently, novel nutritional approaches were investigated to target the bidirectional link between epigenetics and metabolism, whose alteration supports the onset, progression, and therapeutic response of GI cancer patients.
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25
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Alderman B, Allan L, Amano K, Bouleuc C, Davis M, Lister-Flynn S, Mukhopadhyay S, Davies A. Multinational Association of Supportive Care in Cancer (MASCC) expert opinion/guidance on the use of clinically assisted nutrition in patients with advanced cancer. Support Care Cancer 2022; 30:2983-2992. [PMID: 34665311 PMCID: PMC8857106 DOI: 10.1007/s00520-021-06613-y] [Citation(s) in RCA: 15] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/01/2021] [Accepted: 10/03/2021] [Indexed: 01/06/2023]
Abstract
PURPOSE The pro vision of clinically assisted nutrition (CAN) in patients with advanced cancer is controversial, and there is a paucity of specific guidance, and so a diversity in clinical practice. Consequently, the Palliative Care Study Group of the Multinational Association of Supportive Care in Cancer (MASCC) formed a Subgroup to develop evidence-based guidance on the use CAN in patients with advanced cancer. METHODS This guidance was developed in accordance with the MASCC Guidelines Policy. A search strategy for Medline was developed, and the Cochrane Database of Systematic Reviews and the Cochrane Central Register of Controlled Trials were explored for relevant reviews/trials respectively. The outcomes of the review were categorised by the level of evidence, and a "category of guideline" based on the level of evidence (i.e. "recommendation", "suggestion", or "no guideline possible"). RESULTS The Subgroup produced 11 suggestions, and 1 recommendation (due to the paucity of evidence). These outcomes relate to assessment of patients, indications for CAN, contraindications for CAN, procedures for initiating CAN, and re-assessment of patients. CONCLUSIONS This guidance provides a framework for the use of CAN in advanced cancer, although every patient needs individualised management.
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Affiliation(s)
| | | | - Koji Amano
- Department of Palliative Medicine, National Cancer Center Hospital, Tokyo, Japan
| | - Carole Bouleuc
- Department of Supportive and Palliative Care, Institut Curie, Paris, France
| | - Mellar Davis
- Palliative Care Department, Geisinger Medical System, PA, Danville, USA
| | | | | | - Andrew Davies
- School of Medicine, Trinity College Dublin, Dublin, Ireland.
- Education & Research Centre, Our Lady's Hospice Dublin, Harold's Cross, Dublin, Ireland.
- School of Medicine, University College Dublin, Dublin, Ireland.
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26
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SINPE Position Paper on the use of home parenteral nutrition in cancer patients. Support Care Cancer 2022; 30:2909-2914. [PMID: 35037119 DOI: 10.1007/s00520-021-06785-7] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/14/2022]
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27
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SINPE Position Paper on the use of home parenteral nutrition in cancer patients. Nutrition 2022; 95:111578. [DOI: 10.1016/j.nut.2021.111578] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/05/2021] [Accepted: 12/17/2021] [Indexed: 11/20/2022]
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28
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Mulazzani GE, Corti F, Della Valle S, Di Bartolomeo M. Nutritional Support Indications in Gastroesophageal Cancer Patients: From Perioperative to Palliative Systemic Therapy. A Comprehensive Review of the Last Decade. Nutrients 2021; 13:nu13082766. [PMID: 34444926 PMCID: PMC8400027 DOI: 10.3390/nu13082766] [Citation(s) in RCA: 16] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/12/2021] [Revised: 08/04/2021] [Accepted: 08/10/2021] [Indexed: 02/07/2023] Open
Abstract
Gastric cancer treatments are rapidly evolving, leading to significant survival benefit. Recent evidence provided by clinical trials strongly encouraged the use of perioperative chemotherapy as standard treatment for the localized disease, whereas in the advanced disease setting, molecular characterization has improved patients’ selection for tailored therapeutic approaches, including molecular targeted therapy and immunotherapy. The role of nutritional therapy is widely recognized, with oncologic treatment’s tolerance and response being better in well-nourished patients. In this review, literature data on strategies or nutritional interventions will be critically examined, with particular regard to different treatment phases (perioperative, metastatic, and palliative settings), with the aim to draw practical indications for an adequate nutritional support of gastric cancer patients and provide an insight on future directions in nutritional strategies. We extensively analyzed the last 10 years of literature, in order to provide evidence that may fit current clinical practice both in terms of nutritional interventions and oncological treatment. Overall, 137 works were selected: 34 Randomized Clinical Trials (RCTs), 12 meta-analysis, 9 reviews, and the most relevant prospective, retrospective and cross-sectional studies in this setting. Eleven ongoing trials have been selected from clinicaltrial.gov as representative of current research. One limitation of our work lies in the heterogeneity of the described studies, in terms of sample size, study procedures, and both nutritional and clinical outcomes. Indeed, to date, there are no specific evidence-based guidelines in this fields, therefore we proposed a clinical algorithm with the aim to indicate an appropriate nutritional strategy for gastric cancer patients.
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Affiliation(s)
- Giulia E.G. Mulazzani
- Clinical Nutrition Unit, Department of Critical and Supportive Care, Fondazione IRCCS Istituto Nazionale dei Tumori, Via Venezian 1, 20133 Milan, Italy; (G.E.G.M.); (S.D.V.)
| | - Francesca Corti
- Gastrointestinal Medical Oncology, Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Via Venezian 1, 20133 Milan, Italy;
| | - Serena Della Valle
- Clinical Nutrition Unit, Department of Critical and Supportive Care, Fondazione IRCCS Istituto Nazionale dei Tumori, Via Venezian 1, 20133 Milan, Italy; (G.E.G.M.); (S.D.V.)
| | - Maria Di Bartolomeo
- Gastrointestinal Medical Oncology, Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Via Venezian 1, 20133 Milan, Italy;
- Correspondence: ; Tel.: +39-02-2390-2882
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29
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Arends J, Strasser F, Gonella S, Solheim TS, Madeddu C, Ravasco P, Buonaccorso L, de van der Schueren MAE, Baldwin C, Chasen M, Ripamonti CI. Cancer cachexia in adult patients: ESMO Clinical Practice Guidelines ☆. ESMO Open 2021; 6:100092. [PMID: 34144781 PMCID: PMC8233663 DOI: 10.1016/j.esmoop.2021.100092] [Citation(s) in RCA: 262] [Impact Index Per Article: 65.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/21/2020] [Revised: 02/09/2021] [Accepted: 02/24/2021] [Indexed: 12/15/2022] Open
Abstract
•This ESMO Clinical Practice Guideline provides key recommendations for managing cancer-related cachexia. •It covers screening, assessment and multimodal management of cancer cachexia. •All recommendations were compiled by a multidisciplinary group of experts. •Recommendations are based on available scientific data and the author's expert opinion.
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Affiliation(s)
- J Arends
- Department of Medicine I, Medical Center - University of Freiburg Faculty of Medicine, University of Freiburg, Freiburg, Germany
| | - F Strasser
- Integrated Cancer Rehabilitation and Cancer Fatigue Clinic, Klinik Gais/Kliniken Valens; Clinic Medical Oncology and Hematology, Cantonal Hospital St Gallen, St Gallen, Switzerland
| | - S Gonella
- Direction of Health Professions, Azienda Ospedaliero Universitaria Città della Salute e della Scienza of Turin, University of Turin, Turin, Italy; Department of Public Health and Pediatrics, University of Turin, Turin, Italy
| | - T S Solheim
- Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway; Cancer Clinic, Trondheim University Hospital, Trondheim, Norway
| | - C Madeddu
- Medical Oncology Unit, Azienda Ospedaliero Universitaria Cagliari, Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy
| | - P Ravasco
- Immuno-Hemotherapy and Oncology, University Hospital of Santa Maria, CHULN, Lisbon, Portugal; Center for Interdisciplinary Research in Health, Universidade Católica Portuguesa, Lisbon, Portugal; University of Lisbon, Portugal
| | - L Buonaccorso
- Psycho-Oncology Unit, Azienda USL-IRCCS, Reggio Emilia, Italy
| | - M A E de van der Schueren
- Department of Nutrition, Dietetics and Life Style, School of Allied Health, HAN University of Applied Sciences, Nijmegen, The Netherlands; Division of Human Nutrition and Health, Wageningen University & Research, Wageningen, The Netherlands
| | - C Baldwin
- Department of Nutritional Sciences, King's College London, London, UK
| | - M Chasen
- Department of Medicine, University of Toronto, Toronto, Canada; Department of Family Medicine, McMaster University, Hamilton, Canada; William Osler Health Services, Brampton, Canada
| | - C I Ripamonti
- Oncology-Supportive Care in Cancer Unit, Department of Onco-Haematology, Fondazione IRCCS Istituto Nazionale dei Tumori Milano, Milan, Italy
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30
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Salonen BR, Mundi MS, Hurt RT, Bonnes SL. The Role of Parenteral Nutrition for Incurable Cancer: Bridging Expectations and Reality. Curr Nutr Rep 2021; 10:226-231. [PMID: 34047939 DOI: 10.1007/s13668-021-00361-5] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 05/20/2021] [Indexed: 12/12/2022]
Abstract
PURPOSE OF REVIEW In this review, we examine the role for parenteral nutrition (PN) for nutritional support of patients with advanced, incurable cancer with an emphasis on bridging the divide between expectations and reality. RECENT FINDINGS As the rates of cancer have continued to rise worldwide, the utility of PN has continued to be studied. Due to multiple reasons, high-quality research studies have been scarce, and much of the data is based on observational studies. The recent trend appears to support the use of PN in carefully selected patients. Importantly, the effect on quality of life also should be considered when deciding to initiate PN. PN can be a supportive lifeline for patients with advanced, incurable cancer. The medical team should consider each patient individually to decide if PN should be offered. It is of paramount important for the medical team to engage in shared decision-making with the patient and caregiver(s) to ensure that PN is aligned with their goals and wishes.
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Affiliation(s)
- Bradley R Salonen
- Division of General Internal Medicine, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.
| | - Manpreet S Mundi
- Division of Endocrinology, Diabetes, Metabolism and Nutrition, Mayo Clinic, Rochester, MN, USA
| | - Ryan T Hurt
- Division of General Internal Medicine, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.,Division of Endocrinology, Diabetes, Metabolism and Nutrition, Mayo Clinic, Rochester, MN, USA.,Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.,Division of Gastroenterology, Hepatology and Nutrition, University of Louisville, Louisville, KY, USA
| | - Sara L Bonnes
- Division of General Internal Medicine, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA
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31
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Kaegi-Braun N, Schuetz P, Mueller B, Kutz A. Association of Nutritional Support With Clinical Outcomes in Malnourished Cancer Patients: A Population-Based Matched Cohort Study. Front Nutr 2021; 7:603370. [PMID: 33777987 PMCID: PMC7987808 DOI: 10.3389/fnut.2020.603370] [Citation(s) in RCA: 11] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/06/2020] [Accepted: 10/14/2020] [Indexed: 01/07/2023] Open
Abstract
Malnutrition is prevalent in hospitalized cancer patients and has been associated with poor therapy response and unfavorable clinical outcome. While recent studies have shown a survival benefit through nutritional support in a hospitalized malnourished medical population including cancer patients, we aimed to investigate the association of nutritional support with in-hospital mortality and other clinical outcomes in a nationwide inpatient cancer population. In this population-based cohort study, using a large Swiss administrative claims database from April 2013 to December 2018, we created two cohorts of malnourished cancer patients on medical wards. We generated two pairwise cohorts of malnourished patients who received nutritional support by 1:1 propensity-score matching to patients not receiving nutritional support. The primary outcome was all-cause in-hospital mortality. Secondary outcomes were 30-days all-cause hospital readmission and discharge to a post-acute care facility. To account for disease activity, we stratified patients either admitted for cancer as main diagnosis or admitted with cancer as comorbidity. Among 1,851,498 hospitalizations on medical ward, we identified a total of 32,038 malnourished cancer patients. After matching, 11,906 (37%) cases were included in the “cancer main diagnosis cohort” and 5,954 (18.6%) in the “cancer comorbidity cohort.” Patients prescribed a nutritional support showed a lower in-hospital mortality in both cohorts as compared to their respective matched controls not receiving nutritional support [cancer main diagnosis cohort: 15.4 vs. 19.4 %, OR 0.76 (95% CI 0.69–0.83); cancer comorbidity cohort: 7.4 vs. 10.2%, OR 0.71 (95% CI 0.59–0.85)]. While we found no difference in 30-days readmission rates, discharge to a post-acute care facility was less frequent in the nutritional support group of both cohorts. In this large cohort study, nutritional support in hospitalized patients with either cancer as main diagnosis or comorbidity was associated with a lower risk of in-hospital mortality and discharge to a post-acute care facility.
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Affiliation(s)
- Nina Kaegi-Braun
- Division of Endocrinology, Diabetes and Metabolism, University Department of Medicine, Kantonsspital Aarau, Aarau, Switzerland.,Division of General and Emergency Medicine, University Department of Medicine, Kantonsspital Aarau, Aarau, Switzerland
| | - Philipp Schuetz
- Division of Endocrinology, Diabetes and Metabolism, University Department of Medicine, Kantonsspital Aarau, Aarau, Switzerland.,Division of General and Emergency Medicine, University Department of Medicine, Kantonsspital Aarau, Aarau, Switzerland.,Faculty of Medicine, University of Basel, Basel, Switzerland
| | - Beat Mueller
- Division of Endocrinology, Diabetes and Metabolism, University Department of Medicine, Kantonsspital Aarau, Aarau, Switzerland.,Division of General and Emergency Medicine, University Department of Medicine, Kantonsspital Aarau, Aarau, Switzerland.,Faculty of Medicine, University of Basel, Basel, Switzerland
| | - Alexander Kutz
- Division of Endocrinology, Diabetes and Metabolism, University Department of Medicine, Kantonsspital Aarau, Aarau, Switzerland.,Division of General and Emergency Medicine, University Department of Medicine, Kantonsspital Aarau, Aarau, Switzerland
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32
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Bouleuc C, Marchal T, Chvetzoff G, Raynard B, Thiery‐Vuillemin A, Aubry R. In Reply: Randomized Studies Are Needed to Improve Knowledge of Nutritional Interventions for Advanced Cancer Patients. Oncologist 2021; 26:e519-e520. [PMID: 33426725 PMCID: PMC7930414 DOI: 10.1002/onco.13672] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/30/2020] [Accepted: 07/28/2020] [Indexed: 11/06/2022] Open
Abstract
This letter to the editor continues a discussion about parenteral nutrition for patients with advanced cancer and calls for future randomized studies assessing both enteral and parenteral nutrition.
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Affiliation(s)
- Carole Bouleuc
- Department of Supportive Care, Institut CurieParisFrance
| | | | | | - Bruno Raynard
- Tranversal Unit of Nutrition, Institut Gustave RoussyVillejuifFrance
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33
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Cotogni P. Impact of Home Parenteral Nutrition on Quality of Life in Cancer Patients: Don't Throw the Baby Out With the Bath Water. Oncologist 2021; 26:e516-e517. [PMID: 33426743 DOI: 10.1002/onco.13670] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/24/2020] [Accepted: 07/28/2020] [Indexed: 12/14/2022] Open
Affiliation(s)
- Paolo Cotogni
- Pain Management and Palliative Care, Department of Anesthesia, Intensive Care and Emergency, Molinette Hospital, University of Turin, Turin, Italy
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34
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Hamaker ME, Oosterlaan F, van Huis LH, Thielen N, Vondeling A, van den Bos F. Nutritional status and interventions for patients with cancer - A systematic review. J Geriatr Oncol 2021; 12:6-21. [PMID: 32616384 DOI: 10.1016/j.jgo.2020.06.020] [Citation(s) in RCA: 66] [Impact Index Per Article: 16.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/19/2020] [Accepted: 06/15/2020] [Indexed: 12/11/2022]
Abstract
BACKGROUND Malnourishment is commonly seen in ageing, cancer and many chronic conditions, and is associated with poorer prognosis. AIM We set out to collect all currently available evidence on the association between nutritional status assessed with a validated screening tool and prognosis or course of treatment in older patients with cancer, and on the benefit of nutritional interventions in improving these outcomes. METHODS A systematic search in MEDLINE and EMBASE. RESULTS We included 71 studies on the association between nutritional status and outcome in (older) patients with cancer and 17 studies on the benefit of nutritional interventions in improving outcomes in this patient population. There is a significant association between nutritional status and increased intermediate- and long-term mortality (hazard ratio 1.87 (95% confidence interval 1.62-2.17). Those with poorer nutritional status were less likely to complete oncologic treatment according to plan and had higher health care consumption. Benefit of dietary interventions was limited although dietary counselling may lead to improved quality of life while nutritional support may lead to a decrease in post-operative complication rates. CONCLUSION Nutritional status is associated with poorer survival, decreased treatment completion and higher health care consumption and nutritional interventions are only able to negate these negatives outcome to a very limited degree.
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Affiliation(s)
- Marije E Hamaker
- Department of Geriatric Medicine, Diakonessenhuis Utrecht, the Netherlands.
| | - Fleur Oosterlaan
- Department of Geriatric Medicine, University Medical Centre Utrecht, the Netherlands
| | - Lieke H van Huis
- Department of Internal Medicine, Diakonessenhuis Utrecht, the Netherlands
| | - Noortje Thielen
- Department of Internal Medicine, Diakonessenhuis Utrecht, the Netherlands
| | - Ariel Vondeling
- Department of Geriatric Medicine, Diakonessenhuis Utrecht, the Netherlands
| | - Frederiek van den Bos
- Department of Geriatric Medicine, University Medical Centre Utrecht, the Netherlands
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35
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Loofs TS, Haubrick K. End-of-Life Nutrition Considerations: Attitudes, Beliefs, and Outcomes. Am J Hosp Palliat Care 2020; 38:1028-1041. [PMID: 32945174 DOI: 10.1177/1049909120960124] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/05/2023] Open
Abstract
OBJECTIVE To assess the physiological outcomes and interpersonal influences that should be considered when making the decision to provide artificial nutrition and hydration (AN&H) for patients in hospice/palliative programs. METHODS A systematic review was conducted using items from the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols 2015 checklist. Distinct search strategies were employed to find primary research articles that addressed: General health outcomes of artificial nutrition and hydration interventions and nutrition therapy interventions (n = 16), nutrition-related symptoms in end-of-life care (n = 8), and the attitudes of patients and providers toward artificial nutrition and hydration (n = 21). RESULTS The effect of AN&H on health outcomes, quality-of-life measures and nutrition-related symptoms is limited and may vary by patient setting and diagnosis. In the absence of consistent evidence for specific health outcomes, decisions regarding AN&H should be made in context of the desires and beliefs of a patient, their family, and their medical providers. These beliefs may not be consistent with likely outcomes or may be inconsistent between individuals involved in the decision-making process, and individuals of different cultures or geographic regions may approach AN&H decisions from different perspectives. To help navigate the intersection of nutrition-related health outcomes and patient/provider beliefs, palliative care teams may employ a variety of strategies for approaching the decision-making process, and may benefit from specific involvement of a Registered Dietitian to help contribute to or lead these discussions.
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Affiliation(s)
- Tyler S Loofs
- St. David's Georgetown Hospital, Georgetown, TX, USA
| | - Kevin Haubrick
- 165982The University of Houston College of Liberal Arts and Social Sciences, TX, USA
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Cotogni P, Ossola M, Passera R, Monge T, Fadda M, De Francesco A, Bozzetti F. Home parenteral nutrition versus artificial hydration in malnourished patients with cancer in palliative care: a prospective, cohort survival study. BMJ Support Palliat Care 2020; 12:114-120. [PMID: 32826263 DOI: 10.1136/bmjspcare-2020-002343] [Citation(s) in RCA: 16] [Impact Index Per Article: 3.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/08/2020] [Revised: 06/18/2020] [Accepted: 06/29/2020] [Indexed: 12/22/2022]
Abstract
OBJECTIVE The evidence base for home parenteral nutrition (HPN) in patients with advanced cancer is lacking. To compare the survival of malnourished patients with cancer undergoing palliative care who received HPN with a homogeneous group of patients, equally eligible for HPN, who did not receive HPN. DESIGN Prospective, cohort study; tertiary university hospital, home care, hospice. METHODS Patients were assessed for HPN eligibility according to the guidelines. In the eligible population, who received both HPN and chemotherapy was excluded, while who received only HPN was included in the HPN+ group and who received neither HPN nor chemotherapy but artificial hydration (AH) was included in the HPN- group. RESULTS 301 patients were assessed for HPN eligibility and 86 patients (28.6%) were excluded for having severe organ dysfunction or Karnofsky performance status <50. In outcome analysis, 90 patients (29.9%) were excluded for receiving both HPN and chemotherapy, while 125 (41.5%) were included, 89 in HPN+ group (29.5%) and 36 in HPN- group (12%). The survival of the two groups showed a significant difference favouring patients receiving HPN (median overall survival: 4.3 vs 1.5 months, p<0.001). The multivariate analysis of the risk factors for mortality showed that not receiving HPN accounted for the strongest one (HR 25.72, 95% CI 13·65 to 48.44). CONCLUSIONS Comparative survival associated with the use of HPN versus AH showed significantly longer survival in malnourished patients with advanced cancer receiving HPN. These data support the guideline recommendation that HPN should be considered when malnutrition represents the overriding threat for the survival of these patients.
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Affiliation(s)
- Paolo Cotogni
- Internal Medicine, Unit of Parenteral Nutrition in Oncology, Molinette Hospital, Turin, Italy .,Anesthesia, Intensive Care and Emergency, Pain Management and Palliative Care, Molinette Hospital, University of Turin, Turin, Italy
| | - Marta Ossola
- Internal Medicine, Unit of Parenteral Nutrition in Oncology, Molinette Hospital, Turin, Italy.,Internal Medicine, Clinical Nutrition, Molinette Hospital, Turin, Italy
| | - Roberto Passera
- Radiology, Nuclear Medicine Division, Molinette Hospital, Turin, Italy
| | - Taira Monge
- Internal Medicine, Unit of Parenteral Nutrition in Oncology, Molinette Hospital, Turin, Italy.,Internal Medicine, Clinical Nutrition, Molinette Hospital, Turin, Italy
| | - Maurizio Fadda
- Internal Medicine, Clinical Nutrition, Molinette Hospital, Turin, Italy
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Roeland EJ, Bohlke K, Baracos VE, Bruera E, del Fabbro E, Dixon S, Fallon M, Herrstedt J, Lau H, Platek M, Rugo HS, Schnipper HH, Smith TJ, Tan W, Loprinzi CL. Management of Cancer Cachexia: ASCO Guideline. J Clin Oncol 2020; 38:2438-2453. [DOI: 10.1200/jco.20.00611] [Citation(s) in RCA: 154] [Impact Index Per Article: 30.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/30/2022] Open
Abstract
PURPOSE To provide evidence-based guidance on the clinical management of cancer cachexia in adult patients with advanced cancer. METHODS A systematic review of the literature collected evidence regarding nutritional, pharmacologic, and other interventions, such as exercise, for cancer cachexia. PubMed and the Cochrane Library were searched for randomized controlled trials (RCTs) and systematic reviews of RCTs published from 1966 through October 17, 2019. ASCO convened an Expert Panel to review the evidence and formulate recommendations. RESULTS The review included 20 systematic reviews and 13 additional RCTs. Dietary counseling, with or without oral nutritional supplements, was reported to increase body weight in some trials, but evidence remains limited. Pharmacologic interventions associated with improvements in appetite and/or body weight include progesterone analogs and corticosteroids. The other evaluated interventions either had no benefit or insufficient evidence of benefit to draw conclusions on efficacy. Limitations of the evidence include high drop-out rates, consistent with advanced cancer, as well as variability across studies in outcomes of interest and methods for outcome assessment. RECOMMENDATIONS Dietary counseling may be offered with the goals of providing patients and caregivers with advice for the management of cachexia. Enteral feeding tubes and parenteral nutrition should not be used routinely. In the absence of more robust evidence, no specific pharmacological intervention can be recommended as the standard of care; therefore, clinicians may choose not to prescribe medications specifically for the treatment of cancer cachexia. Nonetheless, when it is decided to trial a drug to improve appetite and/or improve weight gain, currently available pharmacologic interventions that may be used include progesterone analogs and short-term (weeks) corticosteroids.
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Affiliation(s)
| | - Kari Bohlke
- American Society of Clinical Oncology, Alexandria, VA
| | | | | | | | | | - Marie Fallon
- Edinburgh Oncology Centre, University of Edinburgh, UK
| | - Jørn Herrstedt
- Zealand University Hospital Roskilde and University of Copenhagen, Denmark
| | - Harold Lau
- University of Calgary, Calgary, Alberta, Canada
| | - Mary Platek
- Roswell Park Comprehensive Cancer Center and D’Youville College, Buffalo, NY
| | - Hope S. Rugo
- University of California San Francisco, San Francisco, CA
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Roeland EJ, Bohlke K, Baracos VE, Bruera E, del Fabbro E, Dixon S, Fallon M, Herrstedt J, Lau H, Platek M, Rugo HS, Schnipper HH, Smith TJ, Tan W, Loprinzi CL. Management of Cancer Cachexia: ASCO Guideline. J Clin Oncol 2020. [DOI: 10.1200/jco.20.00611 10.1200/jco.20.00611] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/06/2023] Open
Abstract
PURPOSE To provide evidence-based guidance on the clinical management of cancer cachexia in adult patients with advanced cancer. METHODS A systematic review of the literature collected evidence regarding nutritional, pharmacologic, and other interventions, such as exercise, for cancer cachexia. PubMed and the Cochrane Library were searched for randomized controlled trials (RCTs) and systematic reviews of RCTs published from 1966 through October 17, 2019. ASCO convened an Expert Panel to review the evidence and formulate recommendations. RESULTS The review included 20 systematic reviews and 13 additional RCTs. Dietary counseling, with or without oral nutritional supplements, was reported to increase body weight in some trials, but evidence remains limited. Pharmacologic interventions associated with improvements in appetite and/or body weight include progesterone analogs and corticosteroids. The other evaluated interventions either had no benefit or insufficient evidence of benefit to draw conclusions on efficacy. Limitations of the evidence include high drop-out rates, consistent with advanced cancer, as well as variability across studies in outcomes of interest and methods for outcome assessment. RECOMMENDATIONS Dietary counseling may be offered with the goals of providing patients and caregivers with advice for the management of cachexia. Enteral feeding tubes and parenteral nutrition should not be used routinely. In the absence of more robust evidence, no specific pharmacological intervention can be recommended as the standard of care; therefore, clinicians may choose not to prescribe medications specifically for the treatment of cancer cachexia. Nonetheless, when it is decided to trial a drug to improve appetite and/or improve weight gain, currently available pharmacologic interventions that may be used include progesterone analogs and short-term (weeks) corticosteroids.
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Affiliation(s)
| | - Kari Bohlke
- American Society of Clinical Oncology, Alexandria, VA
| | | | | | | | | | - Marie Fallon
- Edinburgh Oncology Centre, University of Edinburgh, UK
| | - Jørn Herrstedt
- Zealand University Hospital Roskilde and University of Copenhagen, Denmark
| | - Harold Lau
- University of Calgary, Calgary, Alberta, Canada
| | - Mary Platek
- Roswell Park Comprehensive Cancer Center and D’Youville College, Buffalo, NY
| | - Hope S. Rugo
- University of California San Francisco, San Francisco, CA
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Zanetti M, Gortan Cappellari G, Barazzoni R, Sanson G. The Impact of Protein Supplementation Targeted at Improving Muscle Mass on Strength in Cancer Patients: A Scoping Review. Nutrients 2020; 12:E2099. [PMID: 32708527 PMCID: PMC7400018 DOI: 10.3390/nu12072099] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/22/2020] [Revised: 06/15/2020] [Accepted: 07/03/2020] [Indexed: 12/25/2022] Open
Abstract
Deterioration of muscle strength during cancer results in functional limitation, poor quality of life and reduced survival. The indirect effects on muscle strength of nutritional interventions based on protein and amino acid derivatives targeted at improving muscle mass are poorly documented. A scoping review was performed to examine the available evidence on the effects of proteins, amino acids and their derivatives on muscle strength in adult cancer patients. Pubmed and Scopus databases were searched to identify research articles published in the last 10 years. Fourteen studies met the inclusion criteria, showing that changes in muscle strength following protein or amino acid supplementation are generally concordant with those in muscle mass in cancer patients. Administration of both energy and proteins in the presence of reduced oral intakes results in more robust effects on both muscle strength and mass. It is not clear whether this is due to the correction of the energy deficit or to an interaction between proteins and other macronutrients. The optimal mixture, type, and dose of amino acid/protein supplementation alone or in combination with other anabolic strategies should be determined to provide the best nutritional approach in cancer.
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Affiliation(s)
- Michela Zanetti
- Department of Medical, Surgical and Health Sciences, University of Trieste, 34127 Trieste, Italy; (G.G.C.); (R.B.); (G.S.)
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Ni J, Zhang L. Cancer Cachexia: Definition, Staging, and Emerging Treatments. Cancer Manag Res 2020; 12:5597-5605. [PMID: 32753972 PMCID: PMC7358070 DOI: 10.2147/cmar.s261585] [Citation(s) in RCA: 162] [Impact Index Per Article: 32.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/11/2020] [Accepted: 06/26/2020] [Indexed: 12/26/2022] Open
Abstract
Cachexia is a multifactorial disease characterized by weight loss via skeletal muscle and adipose tissue loss, an imbalance in metabolic regulation, and reduced food intake. It is caused by factors of catabolism produced by tumors in the systemic circulation as well as physiological factors such as the imbalanced inflammatory activation, proteolysis, autophagy, and lipolysis that may occur with gastric, pancreatic, esophageal, lung cancer, liver, and bowel cancer. Cancer cachexia not only negatively affects the quality of life of patients with cancer but also reduces the effectiveness of anti-cancer chemotherapy and increases its toxicity, leading to increased cancer-related mortality and expenditure of medical resources. Currently, there are no effective medical interventions to completely reverse cachexia and no approved drugs. Adequate nutritional support is the main method of cachexia treatment, while drugs that target the inhibition of catabolism, cell damage, and excessive activation of inflammation are under study. This article reviews recent advances in the diagnosis, staging, and evaluation of cancer cachexia.
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Affiliation(s)
- Jun Ni
- Department of Pulmonary and Critical Care Medicine, Peking Union Medical Hospital, Chinese Academy of Medical Science & Peking Union Medical College, Beijing 100730, People's Republic of China
| | - Li Zhang
- Department of Pulmonary and Critical Care Medicine, Peking Union Medical Hospital, Chinese Academy of Medical Science & Peking Union Medical College, Beijing 100730, People's Republic of China
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Pang NI, Bie R, Ung COL, Hu H. Development and Validation of a Logic Model for Utilization of Nutrition Support among Patients with Cancer. BIOMED RESEARCH INTERNATIONAL 2020; 2020:4513719. [PMID: 32685485 PMCID: PMC7334779 DOI: 10.1155/2020/4513719] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 02/03/2020] [Revised: 04/22/2020] [Accepted: 05/29/2020] [Indexed: 11/18/2022]
Abstract
Cancer is the leading cause of morbidity and mortality, and about one in six people die from cancer globally. Approximately 20% to 70% of cancer patients are accompanied with malnutrition, and nutrition support plays an important role among cancer patients. However, the utilization of nutrition support is generally irrational in clinical practices and it is affected by multiple factors. Logic models not only present a framework to improve intervention of health care setting but also identify all the elements, pathways, outcomes, and their relationships between systems. This study developed a logic model of nutrition support for cancer patients based on current literature and conducted interview with medical staff in Macao to validate the logic model. In addition, suggestions were given as references to improve the utilization of nutrition support among cancer patients.
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Affiliation(s)
- Ngou In Pang
- State Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Macao, China
| | - Ruixue Bie
- State Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Macao, China
| | - Carolina Oi Lam Ung
- State Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Macao, China
| | - Hao Hu
- State Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Macao, China
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Lacroix C, Georges G, Thézenas S, Flori N, Francioni L, Janiszewski C, Courraud J, Lecornu H, de Forges H, Senesse P. [The role of the specialist nurse in parenteral nutrition : An observational study of complications with home parenteral nutrition in adult cancer patients]. Rech Soins Infirm 2020; 140:107-116. [PMID: 32524798 DOI: 10.3917/rsi.140.0107] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/14/2022]
Abstract
Background : In France, home parenteral nutrition (HPN) is managed by two parallel healthcare systems : in approved specialist centers (HPN > 12 weeks), and outside of these approved specialist centers (HPN<12 weeks).
Objective : To prospectively evaluate infectious and vascular complications in adult cancer patients undergoing HPN administered via a central venous line, outside of approved specialist HPN centers.
Methods : Our observational prospective study included adult patients with cancer, hospitalized for 48 hours or more, and under HPN. They had a WHO performance status of ≤ 2 and had had a nutritional consultation before discharge.
Results : 25 patients were included in the study, with a median age of 63 years [19–74]. Weight loss of ≥ 5% was reported in 79% of patients. The Ingesta score was < 7 in 96% of cases. 87% of patients presented chill or body temperature variation episodes, with a median of 2 episodes [1–6] per patient. The median delay between end of hospitalization and the first chill episode was 11 days [1–85]. A vascular complication (obstruction without thrombosis) was reported in one patient.
Discussion : This high number of infectious episodes requires improvement of patient care when it comes to strictly adhering to the recommendations. Getting the approved specialist HPN centers to work together and share care protocols could be the first important step.
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Webb N, Fricke J, Hancock E, Trueman D, Ghosh S, Winstone J, Miners A, Shepelev J, Valle JW. The clinical and cost-effectiveness of supplemental parenteral nutrition in oncology. ESMO Open 2020; 5:e000709. [PMID: 32576610 PMCID: PMC7312316 DOI: 10.1136/esmoopen-2020-000709] [Citation(s) in RCA: 13] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/12/2020] [Revised: 03/25/2020] [Accepted: 04/21/2020] [Indexed: 01/09/2023] Open
Abstract
BACKGROUND Clinical guidelines recommend that parenteral nutrition (PN) is added to enteral nutrition (EN; supplemental parenteral nutrition (SPN)) in order to meet energy and protein needs in patients with cancer when EN alone is insufficient. However, although cancer-related malnutrition is common, there is poor awareness of the value of nutritional care, resulting in SPN being chronically underused. METHODS We performed a targeted literature review and exploratory cost-utility analysis to gather evidence on the clinical effectiveness of SPN, and to estimate the potential cost-effectiveness of SPN versus EN alone in an example cancer setting. RESULTS The literature review identified studies linking SPN with malnutrition markers, and studies linking malnutrition markers with clinical outcomes. SPN was linked to improvements in body mass index (BMI), fat-free mass, phase angle (PhA) and prealbumin. Of these markers, BMI and PhA were strong predictors of survival. By combining published data, we generated indirect estimates of the overall survival HR associated with SPN; these ranged from 0.80 to 0.99 (mode 0.87). In patients with Stage IV inoperable pancreatic cancer, the incremental cost-effectiveness ratio versus EN alone was estimated to be £41 350 or £91 501 depending on whether nursing and home delivery costs for EN and SPN were combined or provided separately. CONCLUSION Despite a lack of direct evidence, the results of the literature review demonstrate that SPN may provide important clinical and quality of life benefits to patients with cancer. The potential for any improvement in outcomes in the modelled patient population is very limited, so cost-effectiveness may be greater in patients with less severe disease and other types of cancer.
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Affiliation(s)
- Neil Webb
- Source Health Economics, Oxford, UK.
| | | | | | | | | | | | - Alec Miners
- Department of Health Services Research and Policy, London School of Hygiene and Tropical Medicine, London, London, UK
| | - Julian Shepelev
- Health Economics and Outcomes Research, Clinical Nutrition, Baxter Healthcare Ltd, Compton, UK
| | - Juan W Valle
- Division of Cancer Sciences, The University of Manchester, Manchester, United Kingdom; Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester, United Kingdom
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Goodrose-Flores C, Schedin A, Nelander J, Almerud A, Trolle-Lagerros Y, Bonn S, Björkhem-Bergman L. High-protein compared with standard parenteral nutrition in palliative cancer care. BMJ Support Palliat Care 2020; 12:332-338. [DOI: 10.1136/bmjspcare-2019-002139] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/29/2019] [Revised: 03/27/2020] [Accepted: 05/02/2020] [Indexed: 12/24/2022]
Abstract
ObjectivesHigh-protein parenteral nutrition (PN) has been developed to counteract muscle loss in patients with cancer treated with PN. Nevertheless, it is not clear if high-protein PN is as safe as standard PN in patients with palliative cancer. Our primary aim was to compare the proportion of patients with elevated liver enzymes between high-protein and standard PN in patients with palliative cancer enrolled to Medical Home Care. Our secondary aim was to compare the two treatments with regard to weight and albumin levels during treatment.MethodsMedical records from 2016 to 2018 were retrospectively reviewed to identify palliative cancer patients that had received PN for more than 3 weeks. Data on weight, height, albumin, liver enzymes, socioeconomic factors and dietitian consultations were collected at baseline and after 3–8 weeks of PN treatment. The odds of having elevated liver enzymes or having a maintained weight and/or stable albumin levels were calculated using logistic regression.Results20 patients treated with high-protein PN were compared with 104 patients treated with standard PN. Patients treated with high-protein PN had a significantly higher weight at follow-up compared with patients treated with standard PN (p<0.05). There was no significant difference in the proportion of patients with elevated liver enzymes (OR 0.20; 95% CI 0.02 to 1.86), or maintained weight and/or albumin levels (OR 1.62; 95% CI 0.46 to 5.76) between high-protein and standard PN.ConclusionHigh-protein PN was as safe, and at least as effective, as standard PN to patients with palliative cancer.
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Bozzetti F. Is there a place for nutrition in palliative care? Support Care Cancer 2020; 28:4069-4075. [PMID: 32417968 DOI: 10.1007/s00520-020-05505-x] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/18/2020] [Accepted: 04/27/2020] [Indexed: 12/13/2022]
Abstract
PURPOSE Although nutritional interventions are becoming widely used in cancer patients, purposes and results of such treatment are not always well-defined. This is because nutrition is traditionally considered a palliative treatment to be confined to the area of palliative cares, whereas the modern approach includes nutrition as an early supplemental support to improve compliance of patients with the oncologic therapies and total parenteral nutrition may be recommended in patients who would be destined to succumb prior from starvation-malnutrition than from tumour progression. Purpose of this paper if to define the potential as well as the limitations of nutritional interventions on both the survival and the quality of life of the advanced cancer patients. RECENT FINDINGS Some RCT on the use of oral, enteral and supplemental parenteral nutrition in patients on oncologic therapy show some benefit on compliance with therapy and in some domains of quality of life. Some malnourished (hypo)aphagic incurable cancer patients may survive longer thanks to parenteral nutrition, while few data suggest that quality of life may be maintained for a limited period of time. With a few exceptions, oncology and nutrition have till recently travelled on parallel tracks without talking each other. The oncologist who knows the natural history of the patients should understand which risk of complication and of poor tolerance to the treatment can malnourished patients carry and which is the potential of parenteral nutrition in hypophagic incurable patients.
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Cotogni P, Monge T, Passera R, Brossa L, De Francesco A. Clinical characteristics and predictive factors of survival of 761 cancer patients on home parenteral nutrition: A prospective, cohort study. Cancer Med 2020; 9:4686-4698. [PMID: 32412178 PMCID: PMC7333857 DOI: 10.1002/cam4.3064] [Citation(s) in RCA: 16] [Impact Index Per Article: 3.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/05/2020] [Revised: 03/14/2020] [Accepted: 03/31/2020] [Indexed: 12/22/2022] Open
Abstract
BACKGROUND Robust data reporting the survival of cancer patients on home parenteral nutrition (HPN) are lacking. The aim of this prospective, cohort study was to investigate clinical characteristics, predictive factors, and overall survival (OS) of adult-malnourished cancer patients eligible for HPN according to the European guideline recommendations. METHODS During the study period, 1658 cancer patients were consecutively evaluated in a tertiary university hospital. Of these, 761 who received HPN were grouped into four cohorts according to the provision of supplemental PN (SPN) or total (TPN) and whether they received chemotherapy (CT+ or CT- ): SPN/CT+ (n = 376), TPN/CT+ (n = 99), SPN/CT- (n = 191), and TPN/CT- (n = 95). Patient demographics, nutritional status, cancer-related characteristics, and prognostic scores assessed at HPN start. The primary outcome was OS. RESULTS Median OS was 8.9, 4.3, 5.7, and 2.2 months for the SPN/CT+ , TPN/CT+ , SPN/CT- , and TPN/CT- cohorts, respectively. In multivariable analysis, predictors showing significant association with decreased survival were patient cohorts, modified Glasgow Prognostic Score (1 and 2 scores), weight loss (>15%) in the 3 months before HPN start, and TNM IV stage while protective factors of survival were Karnofsky Performance Status (>50), albumin level (>3.5 g/dL), oral protein intake, BMI (>20.5), and weight at HPN start. CONCLUSION For the first time, in four different cohorts of cancer patients on HPN, clinical characteristics and survival were compared. This large study showed that survival is significantly correlated with patient characteristics at HPN start and that the presence of favorable factors may determine even a fourfold increase in survival. These data are expected to assist physicians in the appropriate prescription of HPN.
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Affiliation(s)
- Paolo Cotogni
- Unit of Parenteral Nutrition in Oncology, Department of Internal Medicine, Molinette Hospital, Turin, Italy
| | - Taira Monge
- Unit of Parenteral Nutrition in Oncology, Department of Internal Medicine, Molinette Hospital, Turin, Italy.,Clinical Nutrition, Department of Internal Medicine, Molinette Hospital, Turin, Italy
| | - Roberto Passera
- Nuclear Medicine Division, Department of Radiology, Molinette Hospital, Turin, Italy
| | - Laura Brossa
- Unit of Parenteral Nutrition in Oncology, Department of Internal Medicine, Molinette Hospital, Turin, Italy.,Clinical Nutrition, Department of Internal Medicine, Molinette Hospital, Turin, Italy
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Bouleuc C, Anota A, Cornet C, Grodard G, Thiery‐Vuillemin A, Dubroeucq O, Crétineau N, Frasie V, Gamblin V, Chvetzoff G, Favier L, Tournigand C, Grach M, Raynard B, Salas S, Capodano G, Pazart L, Aubry R. Impact on Health-Related Quality of Life of Parenteral Nutrition for Patients with Advanced Cancer Cachexia: Results from a Randomized Controlled Trial. Oncologist 2020; 25:e843-e851. [PMID: 32212354 PMCID: PMC7216468 DOI: 10.1634/theoncologist.2019-0856] [Citation(s) in RCA: 57] [Impact Index Per Article: 11.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/09/2019] [Accepted: 02/07/2020] [Indexed: 02/06/2023] Open
Abstract
BACKGROUND Malnutrition worsens health-related quality of life (HRQoL) and the prognosis of patients with advanced cancer. This study aimed to assess the clinical benefits of parenteral nutrition (PN) over oral feeding (OF) for patients with advanced cancer cachexia and without intestinal impairment. MATERIAL AND METHODS In this prospective multicentric randomized controlled study, patients with advanced cancer and malnutrition were randomly assigned to optimized nutritional care with or without supplemental PN. Zelen's method was used for randomization to facilitate inclusions. Nutritional and performance status and HRQoL using the European Organization for Research and Treatment of Cancer QLQ-C15-PAL questionnaire were evaluated at baseline and monthly until death. Primary endpoint was HRQoL deterioration-free survival (DFS) defined as a definitive deterioration of ≥10 points compared with baseline, or death. RESULTS Among the 148 randomized patients, 48 patients were in the experimental arm with PN, 63 patients were in the control arm with OF only, and 37 patients were not included because of early withdrawal or refused consent. In an intent to treat analysis, there was no difference in HRQoL DFS between the PN arm or OF arm for the three targeted dimensions: global health (hazard ratio [HR], 1.31; 95% confidence interval [CI], 0.88-1.94; p = .18), physical functioning (HR, 1.58; 95% CI, 1.06-2.35; p = .024), and fatigue (HR, 1.19; 95% CI, 0.80-1.77; p = .40); there was a negative trend for overall survival among patients in the PN arm. In as treated analysis, serious adverse events (mainly infectious) were more frequent in the PN arm than in the OF arm (p = .01). CONCLUSION PN improved neither HRQoL nor survival and induced more serious adverse events than OF among patients with advanced cancer and malnutrition. Clinical trial identification number. NCT02151214 IMPLICATIONS FOR PRACTICE: This clinical trial showed that parenteral nutrition improved neither quality of life nor survival and generated more serious adverse events than oral feeding only among patients with advanced cancer cachexia and no intestinal impairment. Parenteral nutrition should not be prescribed for patients with advanced cancer, cachexia, and no intestinal failure when life expectancy is shorter than 3 months. Further studies are needed to assess the useful period with a potential benefit of artificial nutrition for patients with advanced cancer.
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Affiliation(s)
- Carole Bouleuc
- INSERM Centre d'Investigation Clinique (CIC) 1431, Centre Hospitalier Universitaire (CHU) BesançonFrance
| | - Amélie Anota
- Methodology and Quality of Life in Oncology Unit (INSERM Unité Mixte de Recherche [UMR] 1098), Centre Hospitalier Universitaire (CHU) BesançonFrance
- French National Platform Quality of Life and CancerBesançonFrance
| | - Cécile Cornet
- INSERM Centre d'Investigation Clinique (CIC) 1431, Centre Hospitalier Universitaire (CHU) BesançonFrance
| | - Ghislain Grodard
- INSERM Centre d'Investigation Clinique (CIC) 1431, Centre Hospitalier Universitaire (CHU) BesançonFrance
- Medical Oncology Department, Centre Hospitalier Universitaire (CHU) BesançonFrance
| | | | | | - Nathalie Crétineau
- Department of Supportive Care, Institut de cancérologie de LorraineVandoeuvre‐lès‐NancyFrance
| | - Véronique Frasie
- Department of Supportive Care, Centre Paul StraussStrasbourgFrance
| | - Vincent Gamblin
- Department of Supportive Care, Centre Oscar LambretLilleFrance
| | | | - Laure Favier
- Medical Oncology Department, Centre Georges‐François LeclercDijonFrance
| | - Christophe Tournigand
- Medical Oncology Department, Hôpital Henri Mondor, Assistance Publique–Hôpitaux de Paris (APHP)CréteilFrance
| | | | - Bruno Raynard
- Tranversal Unit of Nutrition, Institut Gustave RoussyVillejuifFrance
| | - Sébastien Salas
- Medical Oncology Department, Centre Hospitalier (CH) La TimoneMarseilleFrance
| | | | - Lionel Pazart
- INSERM Centre d'Investigation Clinique (CIC) 1431, Centre Hospitalier Universitaire (CHU) BesançonFrance
| | - Régis Aubry
- INSERM Centre d'Investigation Clinique (CIC) 1431, Centre Hospitalier Universitaire (CHU) BesançonFrance
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Pironi L, Boeykens K, Bozzetti F, Joly F, Klek S, Lal S, Lichota M, Mühlebach S, Van Gossum A, Wanten G, Wheatley C, Bischoff SC. ESPEN guideline on home parenteral nutrition. Clin Nutr 2020; 39:1645-1666. [PMID: 32359933 DOI: 10.1016/j.clnu.2020.03.005] [Citation(s) in RCA: 157] [Impact Index Per Article: 31.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/02/2020] [Accepted: 03/06/2020] [Indexed: 02/07/2023]
Abstract
This guideline will inform physicians, nurses, dieticians, pharmacists, caregivers and other home parenteral nutrition (HPN) providers, as well as healthcare administrators and policy makers, about appropriate and safe HPN provision. This guideline will also inform patients requiring HPN. The guideline is based on previous published guidelines and provides an update of current evidence and expert opinion; it consists of 71 recommendations that address the indications for HPN, central venous access device (CVAD) and infusion pump, infusion line and CVAD site care, nutritional admixtures, program monitoring and management. Meta-analyses, systematic reviews and single clinical trials based on clinical questions were searched according to the PICO format. The evidence was evaluated and used to develop clinical recommendations implementing Scottish Intercollegiate Guidelines Network methodology. The guideline was commissioned and financially supported by ESPEN and members of the guideline group were selected by ESPEN.
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Affiliation(s)
- Loris Pironi
- Center for Chronic Intestinal Failure, St. Orsola-Malpighi University Hospital, Bologna, Italy.
| | - Kurt Boeykens
- AZ Nikolaas Hospital, Nutrition Support Team, Sint-Niklaas, Belgium
| | | | - Francisca Joly
- Beaujon Hospital, APHP, Clichy, University of Paris VII, France
| | | | - Simon Lal
- Salford Royal NHS Foundation Trust, Salford, United Kingdom
| | - Marek Lichota
- Intestinal Failure Patients Association "Appetite for Life", Cracow, Poland
| | - Stefan Mühlebach
- Division of Clinical Pharmacy and Epidemiology and Hospital Pharmacy, University of Basel, Basel, Switzerland
| | | | - Geert Wanten
- Intestinal Failure Unit, Radboud University Medical Centre, Nijmegen, the Netherlands
| | - Carolyn Wheatley
- Support and Advocacy Group for People on Home Artificial Nutrition (PINNT), United Kingdom
| | - Stephan C Bischoff
- University of Hohenheim, Institute of Nutritional Medicine, Stuttgart, Germany
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Caccialanza R, Cereda E, Klersy C, Brugnatelli S, Borioli V, Ferrari A, Caraccia M, Lobascio F, Pagani A, Delfanti S, Aprile G, Reni M, Rimassa L, Melisi D, Cascinu S, Battistini L, Candiloro F, Pedrazzoli P. Early intravenous administration of nutritional support (IVANS) in metastatic gastric cancer patients at nutritional risk, undergoing first-line chemotherapy: study protocol of a pragmatic, randomized, multicenter, clinical trial. Ther Adv Med Oncol 2020; 12:1758835919890281. [PMID: 32127922 PMCID: PMC7036492 DOI: 10.1177/1758835919890281] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/26/2019] [Accepted: 10/29/2019] [Indexed: 12/15/2022] Open
Abstract
Background Malnutrition is common in cancer patients, particularly in those affected by gastrointestinal malignancies, and negatively affects treatment tolerance, survival, functional status, and quality of life (QoL). Nutritional support, including supplemental parenteral nutrition (SPN), has been recommended at the earliest opportunity in malnourished cancer patients. The limited available evidence on the efficacy of SPN in gastrointestinal cancer patients is positive, particularly with regards to QoL, body composition, and energy intake, but the evidence on survival is still scanty. Furthermore, studies regarding the early administration of SPN in combination with nutritional counseling from the beginning of first-line chemotherapy (CT) are lacking. We hypothesize that early systematic SPN in combination with nutritional counseling (NC), compared with NC alone, can benefit patients with previously untreated metastatic gastric cancer at nutritional risk undergoing first-line CT. Methods The aim of this pragmatic, multicenter, randomized (1:1), parallel-group, open-label, controlled clinical trial is to evaluate the efficacy in terms of survival, weight maintenance, body composition, QoL and feasibility of cancer therapy of early systematic SNP. This is in combination with NC, compared with NC alone, in treatment-naïve metastatic gastric cancer patients at nutritional risk undergoing first-line CT. Discussion Malnutrition in oncology remains an overlooked problem. Although the importance of SPN in gastrointestinal cancer patients has been acknowledged, no studies have yet evaluated the efficacy of early SPN in metastatic gastric patients undergoing CT. The present study, which guarantees the early provision of nutritional assessment and support to all the enrolled patients in accordance with the recent guidelines and recommendations, could represent one of the first proofs of the clinical effectiveness of early intensive nutritional support in cancer patients undergoing CT. This study could stimulate further large randomized trials in different cancer types, potentially resulting in the improvement of supportive care quality. Trial registration This study is registered on ClinicalTrials.gov: NCT03949907.
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Affiliation(s)
- Riccardo Caccialanza
- Clinical Nutrition and Dietetics Unit, Fondazione IRCCS Policlinico San Matteo, Viale Golgi 19, Pavia 27100, Italy
| | - Emanuele Cereda
- Clinical Nutrition and Dietetics Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
| | - Catherine Klersy
- Biometry and Clinical Epidemiology Service, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
| | - Silvia Brugnatelli
- Medical Oncology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
| | - Valeria Borioli
- Clinical Nutrition and Dietetics Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
| | - Alessandra Ferrari
- Medical Oncology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
| | - Marilisa Caraccia
- Clinical Nutrition and Dietetics Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
| | - Federica Lobascio
- Clinical Nutrition and Dietetics Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
| | - Anna Pagani
- Medical Oncology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
| | - Sara Delfanti
- Medical Oncology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
| | - Giuseppe Aprile
- Department of Oncology, San Bortolo General Hospital, Vicenza, Italy
| | - Michele Reni
- Department of Medical Oncology, IRCCS San Raffaele Scientific Institute, Milan, Italy
| | - Lorenza Rimassa
- Medical Oncology and Hematology Unit, Humanitas Clinical and Research Center IRCCS, Rozzano (Milan), Italy
| | - Davide Melisi
- Digestive Molecular Clinical Oncology Research Unit, Section of Medical Oncology, Department of Medicine, University of Verona, Verona, Italy
| | - Stefano Cascinu
- Department of Oncology and Hematology, University Hospital of Modena, Modena, Italy
| | - Luca Battistini
- Neuroimmunology Unit, IRCCS Santa Lucia Foundation, Rome, Italy
| | | | - Paolo Pedrazzoli
- Medical Oncology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
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Abstract
OPINION STATEMENT Sarcopenia is being consistently recognized as a condition not only associated with the presence of a malignancy but also induced by the oncologic therapies. Due to its negative impact on tolerance to chemotherapy and final outcome in both medical and surgical cancer patients, sarcopenia should be always considered and prevented, and, if recognized, should be appropriately treated. A CT scan at the level of the third lumbar vertebra, using an appropriate software, is the more common and easily available way to diagnose sarcopenia. It is now acknowledged that mechanisms involved in iatrogenic sarcopenia are several and depending on the type of molecule included in the regimen of chemotherapy, different pharmacologic antidotes will be required in the future. However, progression of the disease and the associated malnutrition per se are able to progressively erode the muscle mass and since sarcopenia is the hallmark of cachexia, the therapeutic approach to chemotherapy-induced sarcopenia parallels that of cachexia. This approach mainly relies on those strategies which are able to increase the lean body mass and include the use of anabolic/anti-inflammatory agents, nutritional interventions, physical exercise and, even better, a combination of different therapies. There are some phase II studies and some small controlled randomized trials which have validated these treatments using single agents or combined multimodal approaches. While these approaches may require the cooperation of some specialists (nutritionists with a specific knowledge on pathophysiology of catabolic states, accredited exercise physiologists and physiotherapists), the oncologist too should directly enter these issues to coordinate the choice and priority of the treatments. Who better than the oncologist knows the natural history of the disease, its evolution, and the probability of tolerance and response to the oncologic therapy? Only the oncologist knows when it is essential to potentiate any effort to better achieve a control of the disease, using all the available armamentarium, and when the condition is too advanced and hence requires a more palliative than supporting care. The oncologist also knows when to expect a gastrointestinal toxicity (mucositis, nausea, vomiting, and diarrhea) and hence it is more convenient using a parenteral than an enteral nutritional intervention or, on the contrary, when patient is suitable for discharge from hospital and oral supplements should be promptly tested for compliance and then prescribed. When patients are at high risk for malnutrition or if, regardless of their nutritional status, they are candidate to aggressive and potentially toxic treatments, they should undergo a jointed evaluation by the oncologist and the nutritionist and physical therapist to assess together a combined approach. In conclusion, the treatment of both cancer- or chemotherapy-related sarcopenia represents a challenge for the modern oncologist who must be able to coordinate a new panel of specialists with the same skill necessary to decide the priority of different oncologic treatments within a complex multidisciplinary context.
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