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

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 been recognized as one of the effective intervention for preventing CIPN. This study aims to examine the efficacy and safety of acupuncture for preventing 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 and are diagnosed as colorectal cancer undergoing oxaliplatin based chemotherapy, will be randomized in a ratio of 1:1 to acupuncture group and sham-controlled group. During 12-weektreatment period, patients in acupuncture group will undergo acupuncture once a week from the first cycle of chemotherapy, patients in control group will receive sham-acupuncture, and the patients in both groupswill 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), vibration and light touch sense test, quality of life questionnaire-C30 of European Organization for Research and Treatment of Cancer (EQRTC) (EORTC QLQ-C30) and Constitution of Chinese Medicine Questionnaire (CCMQ). Discussion: The study will compare acupuncture with sham acupuncture and will obtain evidence for utilizing acupuncture for chemotherapy induced peripheral neuropathy.