Efficacy of a plant-based diet on FOLFOX chemotherapy-induced gastrointestinal toxicity in patients with colorectal cancer: study protocol for a multicentre, stratified, randomised controlled trial
Abstract
Background: Gastrointestinal toxicity during FOLFOX chemotherapy for colorectal cancer (CRC) is frequent and can impair oral intake, quality of life, and planned chemotherapy delivery. Safe and scalable dietary strategies are needed as adjuncts to standard supportive care. This trial will evaluate whether a structured plant-based dietary strategy reduces chemotherapy-induced gastrointestinal toxicity (CIGT) and improves related biological and patient-centered outcomes.
Methods: This multicentre, stratified, three-arm, parallel-group, assessor-blinded, superiority randomised controlled trial will enrol 114 adults (18-65 years) with pathologically confirmed CRC receiving (or scheduled to receive) FOLFOX chemotherapy at two hospitals in Chengdu, China. Participants will be randomised (1:1:1), stratified by study site and sex, to (1) a structured plant-based dietary strategy, (2) conventional dietary guidance, or (3) conventional dietary guidance plus an oncology complete nutritional formula, for 6 weeks. Assessments will be performed at baseline and at prespecified time points through week 6. Primary outcomes are (i) the participant-level incidence of any prespecified CTCAE gastrointestinal toxicity of grade ≥ 2 during follow-up, (ii) serum inflammatory biomarkers, and (iii) stool-based profiling. Secondary outcomes include dietary intake and diet quality, body composition by bioelectrical impedance analysis, routine clinical laboratory indices, fatigue, anxiety/depression,…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 114 participants or records.
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