Background: Cachexia is prevalent in gastrointestinal cancers and worsens patient outcomes and chemotherapy compliance. This study reports on the characteristics of gastrointestinal cancer chemotherapy clinical trials and whether measures and related symptoms of cachexia are recorded as outcomes.
Methods: Public trial registries (2012–2022) were accessed for Phase II and/or III randomised controlled pancreatic, gastric and colorectal cancer chemotherapy trials. Descriptive statistics and chi-square tests examined associations between outcomes and trial characteristics (p<0.05).
Results: Four registries and 540 trials were analysed, with most trials from Europe (44.1%). Pancreatic (35.2%), colorectal (33.3%) and gastric (31.5%) trials mostly recorded overall survival (90.4%) and toxicity (78.9%), and the symptoms appetite loss (26.1%) and diarrhoea (19.1%). Outcome measures physical activity, appetite loss, pain and nausea were significantly associated with cancer type and trial location. Lead investigator was from academia (28.3%), industry (27.6%) and government (26.3%). Trial funding was predominantly from private/industry (34.3%), and significantly associated with overall survival, weight/BMI, caloric intake and pain. Allied health professional involvement was 26.9%. Adjuvant therapy was mainly treatment-related (68.1%). Additional medication included anti-nausea (2.2%) and analgesia (0.9%). Specific screening or assessment tools were used in 91.2% and 46.3% of the trials, respectively, with significant associations between assessment tools and outcomes except for overall survival, lean muscle mass and oral mucositis. Trial year was associated with measuring weight/body mass index.
Conclusions: Cachexia outcomes were under-recorded in gastrointestinal cancer chemotherapy trials. As trial patients experience a high symptom burden, cachexia-relevant quality-of-life tools should be integrated with primary endpoints to provide a complete picture of their progress.