Effects of a fasting-mimicking diet on long-term prognosis in patients with colorectal cancer undergoing radical resection: protocol for a multicentre, prospective, randomised controlled trial.

INTRODUCTION

Given the metabolic vulnerability of colorectal cancer (CRC) cells, periodic fasting-mimicking diets (FMDs) have emerged as a promising dietary strategy for improving clinical outcomes. Although preclinical studies have suggested that FMDs may suppress tumour growth and early-phase clinical trials have demonstrated their safety and feasibility, evidence regarding their effects on long-term survival outcomes in CRC remains limited because of certain constraints in patient cohorts and study designs.

METHOD AND ANALYSIS: This multicentre, prospective, randomised controlled trial will be conducted at six tertiary comprehensive hospitals in China. It is anticipated that 602 eligible participants with clinical stage III CRC will be recruited. Participants will be randomly assigned at a 1:1 ratio to either the FMD group or the control group. After the 4-month dietary intervention, participants will continue to be followed up for 3 years. The primary outcome is 3-year disease-free survival. Participant enrolment began in June 2022, and the study is expected to be completed in December 2027.

ETHICS AND DISSEMINATION: The study protocol was approved by the ethics committees of Zhongshan Hospital, Fudan University and other participating centres. The findings of this study will be disseminated through publication in peer-reviewed journals and presentation at academic conferences.

TRIAL REGISTRATION NUMBER: NCT05384444.