Efficacy and safety of warm acupuncture in oxaliplatin-induced chronic peripheral neuropathy: a multicentre, randomized controlled trial protocol.

INTRODUCTION: Oxaliplatin-induced chronic peripheral neuropathy (OICPN) is a prevalent side effect experienced by patients receiving chemotherapy that primarily manifests as ongoing numbness in the limbs that can persist after treatment ends. This condition significantly diminishes quality of life and frequently leads to dose reduction or early treatment cessation, compromising antitumor efficacy. However, a universally accepted and effective approach for the prevention or treatment of OICPN is currently unavailable. In our clinical observations, we have noted that warm acupuncture may relieve the symptoms of patients experiencing OICPN. Consequently, we propose this randomized controlled trial (RCT) to rigorously assess the safety and effectiveness of warm acupuncture for OICPN patients with the goal of providing preliminary evidence for its use in clinical settings. METHODS AND ANALYSIS: This study is a multicentre, randomized, controlled clinical trial involving 84 patients diagnosed with OICPN. Participants will be randomly divided into two groups in a 1:1 ratio to receive either standard care alone or warm acupuncture plus standard care. This regimen will include 16 sessions, with treatments occurring twice a week for the first month and once a week for the subsequent 2 months. All participants will complete the 12-week program and one-year follow-up. Outcomes will be assessed by blinded evaluators. The primary outcome is neurotoxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0. Secondary outcomes include the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy 20-item scale (EORTC QLQ-CIPN20) and the European Organization for Research and Treatment of Cancer Quality of Life Core 30 Questionnaire (EORTC QLQ-C30), measured at baseline, week 2, month 1, post-treatment, and during follow-up. CLINICAL TRIAL REGISTRATION: https://www.chictr.org.cn/index.html, ChiCTR2400082506.