Efficacy and safety of auricular acupressure for chemotherapy-induced peripheral neuropathy among patients with breast cancer: a study protocol for a randomized controlled trial.

ABSTRACT

BACKGROUND: Chemotherapy-induced peripheral neuropathy (CIPN) is a frequently-reported distress symptom in breast carcinoma patients under chemotherapy. Although previous studies emphasized lack of ideal neuroprotective or therapeutic agents for CIPN, there are no strongly recommended treatments. Nevertheless, auricular acupressure (AA) is a novel remedy for controlling symptoms in many healthcare settings. However, therapeutic effects of AA among patients with CIPN have not yet been elucidated fully. Therefore, we designed a trial to examine the effectiveness and safety of AA in breast cancer patients. METHODS: This randomized, double-blind, sham-controlled trial will assess 120 breast cancer survivors. After enrollment, the participants will be stratified depending on administration of medications prescribed for CIPN treatment, and then assigned randomly to the experimental or control groups in an allocation ratio of 11. For experimental groups, AA will be applied on four points, namely, shemen, liver, spleen, and finger/toe, while for the control groups, sham AA will be exerted on other four points that are remote from the treatment points and unrelated to neuropathic symptoms. All participants will undergo the same acupressure procedure, for two minutes each time, thrice daily for 3 weeks, and CIPN symptoms and health-related quality of life will be assessed by a blinded research assistant and a physician before, during, immediately after, and 4 weeks after AA. Occurrence, type, and severity of safety issues will be routinely monitored to confirm the non-toxic nature of AA. Repeated measures analysis of variance will be used to examine the changing pattern of CIPN symptoms and based on sensitivity analysis. DISCUSSION: It is expected that the rationale and design of this protocol will offer knowledge regarding a standardized process to guide current and future studies and accumulates clinical experiences in applying non-pharmacological intervention. The present trial is the first to examine the therapeutic effects of AA in breast cancer patients with CIPN. The findings of the study may provide convincing evidence regarding the effectiveness of CIPN symptoms. TRIAL REGISTRAION Clinical Research Information Service, Republic of Korea, ID KCT0004930. Registered retrospectively on April 14, 2020.