Acupuncture for preventing chemotherapy-induced peripheral neuropathy: study protocol for a randomised controlled trial.

INTRODUCTION

Chemotherapy-induced peripheral neuropathy (CIPN) is the most prevalent non-haematological, dose-limiting adverse event associated with platinum derivatives and taxanes. Currently, no effective prophylactic interventions for CIPN have been established. However, several studies have shown that acupuncture may alleviate symptoms of peripheral neuropathy, proposing it as a potentially effective strategy for CIPN prevention. This pilot trial will help determine the feasibility and efficacy of acupuncture for preventing CIPN. The results will provide valuable insights for designing a larger clinical trial and conducting power calculations.

METHODS AND ANALYSIS

This is a randomised sham-controlled trial. A cohort of 60 patients scheduled to receive chemotherapy will be enrolled and randomly assigned to either the electroacupuncture group or the sham acupuncture group. Eligible patients will receive nine treatment sessions administered over the course of three chemotherapy cycles. The primary outcome is the change in CIPN-related quality of life (QOL) measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) CIPN20 from baseline to the end of cycle three. Secondary outcomes include: neurotoxicity symptoms assessed by the Numeric Rating Scale, incidence of CIPN, chemotherapy status, insomnia symptoms measured by the Insomnia Severity Index, depression symptoms evaluated using the Beck Depression Inventory-II, anxiety symptoms assessed with the Generalised Anxiety Disorder-7 and fatigue symptoms measured by the Brief Fatigue Inventory. Adverse events will be meticulously recorded.

ETHICS AND DISSEMINATION

The study protocol (V.1.0, 29 July 2024) has been approved by the First Affiliated Hospital of Zhengzhou University (2024-KY-0853-001). All patients will provide oral informed consent and written informed consent before participating in this study. Trial results will be disseminated in peer-reviewed publications.

TRIAL REGISTRATION NUMBER

ITMCTR2024000390 (International Traditional Medicine Clinical Trial Registry, http://itmctr.ccebtcm.org.cn/zh-CN/Home/ProjectView?pid=16387992-8971-4218-9cd0-b623af91f9f3), registered on 3 September 2024.