Electroacupuncture for chemotherapy-induced gastrointestinal symptoms in colorectal cancer: protocol for a...

Colorectal cancer (CRC) is the second leading cause of cancer-related mortality globally. While chemotherapy remains a cornerstone of CRC treatment, gastrointestinal (GI) toxicity-manifesting as abdominal pain, diarrhea, constipation, and reflux-affects 40%-100% of patients, severely impairing quality of life. Despite the prevalence of these symptoms, there is a lack of effective non-pharmacological interventions. This study aims to evaluate the efficacy of electroacupuncture (EA) in alleviating chemotherapy-induced GI dysfunction in CRC patients.

In this multicenter, three-arm, randomized controlled trial (RCT), 231 CRC patients with post-chemotherapy GI symptoms will be centrally randomized to EA plus standard care, sham acupuncture (SA) plus standard care, or standard care alone. The EA and SA groups will receive three 30-min sessions over consecutive days, delivered by certified acupuncturists (EA: LI11, PC6, ST36 and ST37 with electrical stimulation; SA: non-acupoints with blunt-tip needles without stimulation). The primary outcome is the change in Gastrointestinal Symptom Rating Scale (GSRS) total scores from baseline to post-treatment (day 3). Secondary outcomes include GSRS subscale scores, Functional Assessment of Cancer Therapy-Colorectal (FACT-C) scores, and Self-Rating Anxiety Scale/Self-Rating Depression Scale (SAS/SDS) scores. All outcomes will be assessed at baseline (T0), post-intervention (T1: day 3), and follow-up (T2: day 10). Statistical analysis will employ intention-to-treat linear mixed-effects models.

This multicenter RCT is designed to generate high-quality evidence on the comprehensive efficacy of EA in addressing chemotherapy-induced GI toxicity in CRC patients. If proven effective, EA could provide a safe, non-pharmacological adjunct to standard care, helping to reduce symptom burden and improve patient adherence to chemotherapy. Trial registration ChiCTR2200062317. Registered on 1 August 2022.