The efficacy and safety of electro-acupuncture for alleviating chemotherapy-induced peripheral neuropathy in colorectal cancer patients: study protocol for a pilot 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 Practice. This pilot study aims to examine the efficacy and safety of acupuncture for alleviating CIPN in colorectal cancer patients in Hong Kong. Methods/Design: This is a pilot single-blinded, randomized, sham-controlled 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 1:1 to electro-acupuncture group and sham-controlled group. During a 12-week treatment period, patients in electro-acupuncture group will undergo electro-acupuncture once a week from the first cycle of chemotherapy, patients in control group will receive sham-acupuncture, and the patients in both groups will be followed up for twelve 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, quality of life questionnaire-C30 of European Organization for Research and Treatment of Cancer (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.