Electroacupuncture for Managing Chemotherapy‐Induced Gastrointestinal Symptom Clusters in Patients With Breast Cancer: Study Protocol for a Randomized Controlled Trial

Introduction Chemotherapy‐induced gastrointestinal symptom clusters in breast cancer impair quality of life and treatment adherence, yet lack effective interventions. While acupuncture mitigates isolated chemotherapy‐induced symptoms, its mechanisms for multi‐symptom clusters remain unclear. This study evaluates electroacupuncture's efficacy and explores its biological mechanisms in managing these clusters. Methods This prospective, multicenter, block‐randomized, double‐blind, sham‐controlled trial will enroll 388 patients with breast cancer undergoing neoadjuvant/adjuvant chemotherapy, to be randomly assigned (1:1) to electroacupuncture or sham electroacupuncture groups. Both groups will receive the standard quadruple antiemetic regimen combined with electroacupuncture or sham intervention. The primary endpoint is the incidence of chemotherapy‐induced gastrointestinal symptom clusters within 120 h after chemotherapy. Secondary endpoints include improvement in gastrointestinal symptom clusters post‐first chemotherapy cycle, nausea‐free rates during acute and delayed phases, vomiting‐free rates during overall, acute, and delayed phases, complete response rate, complete protection rate, and quality of life. Adverse events will be documented throughout the study. Discussion This study will assess the efficacy and safety of electroacupuncture in alleviating chemotherapy‐induced gastrointestinal symptom clusters in patients with breast cancer. By integrating multi‐omics analyses, we aim to elucidate the biological mechanisms underlying its therapeutic effects. The findings may offer a robust clinical foundation for optimizing symptom cluster management in cancer care. Trial Registration: Clinical Trials ID: NCT06952920. Date of registration: April 16, 2025. Prospectively registered. URL of Trial Registry Record: https://clinicaltrials.gov/study/NCT06952920cond=NCT06952920&rank=1 .