Phase II Study of Acupuncture for Treating Oxaliplatin-Induced Nerve Pain in Patients With Gastro-intestinal Cancers Who Stopped Oxaliplatin Chemotherapy

What this Trial Is About

Researchers are evaluating the effects of a standardized acupuncture protocol on oxaliplatin-induced peripheral neuropathy in patients with gastrointestinal solid tumors who have stopped oxaliplatin-containing chemotherapy. This phase II, multicenter, open-label study includes two cohorts one randomized into two groups and one single-arm group. The study follows acupuncture treatment guidelines to ensure consistent delivery by trained physician acupuncturists. Participants in the randomized cohort are assigned to either receive weekly acupuncture for six weeks or no acupuncture for six weeks. Those receiving acupuncture get sessions targeting eight specific acupoints each week. At week 7, outcomes are assessed, and patients in the acupuncture group may choose to continue treatment for another six weeks. In the non-acupuncture group, patients with higher symptom scores at week 7 receive acupuncture for six weeks, while others do not. Throughout the study, participants undergo evaluations including symptom rating scales, quality of life questionnaires related to chemotherapy-induced neuropathy, pain inventories, and neuropathy grading at several points up to six months. Researchers monitor symptoms to measure improvement and track safety. The total involvement includes regular acupuncture sessions, assessments at baseline, weeks 7, 14, and follow-up at six months to observe lasting effects.

Acupuncture for Oxaliplatin-induced Peripheral Neuropathy in Gastro-intestinal Cancer Patients