Are measures and related symptoms of cachexia recorded as outcomes in gastrointestinal cancer chemotherapy clinical trials?

Q: What was the study trying to determine about cachexia in clinical trials?

The study assessed how much registered gastrointestinal cancer chemotherapy clinical trials record cachexia measures and related symptoms as outcomes, and whether this recording is linked to trial characteristics.

Q: Which trial registries and trial types were included?

The researchers accessed four public trial registries covering 2012–2022 and examined phase II and/or III randomized controlled chemotherapy trial protocols for pancreatic, gastric, and colorectal cancer.

Q: What did the results show about recording cachexia-related outcomes?

Cachexia-related outcomes were under-recorded. While many protocols reported overall survival and toxicity, specific cachexia symptoms and measures were recorded in fewer trials, and reporting differed by cancer type, location, and funding.

Sep 22, 2026

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Cachexia affects gastrointestinal cancer patients and can worsen clinical outcomes and adherence to chemotherapy. The study evaluated how extensively registered gastrointestinal cancer chemotherapy phase II/III randomized trials record cachexia measures and related symptoms as clinical trial outcomes, and whether reporting varies by trial characteristics. Four public trial registries (2012–2022) were searched, and extracted outcome measures, symptom items, and performance-status or PRO tools were analyzed descriptively and with chi-square tests.

LanguageEnglish

CategoryResearch & Report

FormatPDF

Pages11

Reading Time28 min

AccessFree to download

Abstract

Background

Methods

Results

Conclusions

Introduction

ORIGINAL ARTICLE Journal of Cachexia, Sarcopenia and Muscle 2024; 15: 1146–1156 Published online 27 March 2024 in Wiley Online Library ([wileyonlinelibrary.com)](wileyonlinelibrary.com) DOI: 10.1002/jcsm.13458)[ DOI:](wileyonlinelibrary.com) DOI: 10.1002/jcsm.13458)[ 10.1002/jcsm.13458](wileyonlinelibrary.com) DOI: 10.1002/jcsm.13458) Are measures and related symptoms of cachexia recorded as outcomes in gastrointestinal cancer chemotherapy clinical trials? Ross Valaire1 , Frances Garden1 & Valentina Razmovski-Naumovski1,2,3 * 1Faculty of Medicine & Health, South West Sydney Clinical Campuses, University of New South Wales (UNSW) Sydney, Kensington, NSW, Australia; 2School of Medicine, Western Sydney University, Campbelltown, NSW, Australia; 3Ingham Institute of Applied Medical Research, Sydney, NSW, Australia Abstract Background Cachexia is prevalent in gastrointestinal cancers and worsens patient outcomes and chemotherapy compliance. We examined to what extent registered gastrointestinal cancer chemotherapy clinical trials record measures and related symptoms of cachexia as outcomes, and whether these were associated with trial characteristics. Methods Four public trial registries (2012–2022) were accessed for Phase II and/or III randomized controlled pancreatic, gastric, and colorectal cancer chemotherapy trial protocols. Trial outcome measures of overall survival and toxicity/side effects, and those related to cachexia [physical activity, weight/body mass index (BMI), dietary limitations, caloric intake, lean muscle mass] and symptoms (appetite loss, diarrhoea, pain, fatigue/insomnia, constipation, nausea, vomiting, and oral mucositis) were extracted, along with the number and types of performance status and patient-reported outcomes (PROs) tools. Data were summarized descriptively. Chi-square tests examined associations between outcomes and trial characteristics (cancer type, trial location, funding source, PROs tools, and commencement year) . Statistical signiﬁcance was set at P < 0.05. Results We included 540 trial protocols (pancreatic (35.2%), colorectal (33.3%) and gastric (31.5%)), with most trials from Europe (44.1%) . Trial lead investigator was from academia (28.3%), industry (27.6%) and government (26.3%). Allied health professional involvement (26.9%) occurred at eligibility. Adjuvant therapy in trials was mainly treatment-related (68.1%) . Additional medication included anti-nausea (2.2%) and analgesia (0.9%) . Trial protocols mostly recorded overall survival (90.4%) and toxicity (78.9%), and the symptoms appetite loss (26.1%) and diarrhoea (19.1%), with the other symptoms recorded in <10% of the trials. Reporting of physical activity (P = 0.001), dietary limitations (P = 0.002), lean muscle mass (P = 0.027), appetite loss (P < 0.001), pain (P = 0.001), nausea (P = 0.012), and oral mucositis (P = 0.049) varied depending cancer type. Toxicity/side effects (P = 0.022), physical activity (P < 0.001), appetite loss, nausea, and vomiting (all P < 0.001), diarrhoea (P = 0.010), pain (P = 0.001), fatigue/insomnia (P = 0.001) varied depending on the trial location. Trial funding was predominantly from private/industry (34.3%) and inﬂuenced the reporting of overall survival (P = 0.049), weight/BMI (P = 0.005), caloric intake (P = 0.015), and pain (P = 0.031) . Performance status and PROs tools were mentioned in 91.2% and 46.3% of the trials, respectively. Trials that incorporated PROs tools were more likely to report cachexia related outcomes, except for overall survival, lean muscle mass, and oral mucositis. The proportion of trials measuring weight/BMI increased with trial commencement year (P = 0.04) . Conclusions Cachexia-related outcomes were under-recorded in gastrointestinal cancer chemotherapy trials. As trial patients experience a high symptom burden, cachexia-relevant measures and symptoms should be assessed throughout the trial, and integrated with primary endpoints to support their prog

FAQs

What was the study trying to determine about cachexia in clinical trials?

The study assessed how much registered gastrointestinal cancer chemotherapy clinical trials record cachexia measures and related symptoms as outcomes, and whether this recording is linked to trial characteristics.

Which trial registries and trial types were included?

The researchers accessed four public trial registries covering 2012–2022 and examined phase II and/or III randomized controlled chemotherapy trial protocols for pancreatic, gastric, and colorectal cancer.

What did the results show about recording cachexia-related outcomes?

Cachexia-related outcomes were under-recorded. While many protocols reported overall survival and toxicity, specific cachexia symptoms and measures were recorded in fewer trials, and reporting differed by cancer type, location, and funding.

Sep 22, 2026

Upload by Violet