The efficacy and safety of electro-acupuncture for alleviating chemotherapy-induced peripheral neuropathy in patients with coloreactal cancer: study protocol for a single-blinded, randomized sham-controlled trial.

ABSTRACT

BACKGROUND: Colorectal cancer is the most common cancer in Hong Kong. Oxaliplatin-based chemotherapy is a major first-line conventional therapy for advanced and metastatic colorectal cancer. However, oxaliplatin causes chemotherapy-induced peripheral neuropathy (CIPN). Acupuncture has long been used to alleviate limb numbness in Chinese medicine. This study aims to examine the efficacy and safety of acupuncture for alleviating CIPN in patients with colorectal cancer in Hong Kong. METHODS/DESIGN: This is a single-blinded, randomized, sham-controlled efficacy trial. Eighty-four eligible patients, who are Hong Kong Chinese, aged ≥ 18 years, diagnosed with colorectal cancer and undergoing oxaliplatin-based chemotherapy, will be randomized in a ratio of 11 to the electro-acupuncture group or the sham-controlled group. During a 12-week treatment period, patients in the electro-acupuncture group will undergo electro-acupuncture once a week from the first cycle of chemotherapy, while patients in the control group will receive sham acupuncture, and the patients in both groups will be followed up for 12 weeks. The primary outcome measure is the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOC-Ntx) questionnaire. The secondary outcome measures include numerical rating scale (NRS) for numbness/pain, vibration and light touch sense test, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) and Constitution of Chinese Medicine Questionnaire (CCMQ). DISCUSSION: The study will compare electro-acupuncture with sham acupuncture to explore the feasibility for electro-acupuncture in improving symptoms caused by chemotherapy-induced peripheral neuropathy. TRIAL REGISTRATION Clinicaltrials.gov, NCT03582423. Registered on 11 July 2018.