The efficacy and safety of electro-acupuncture for alleviating chemotherapy-induced peripheral neuropathy in colorectal cancer patients: 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 Practice. This 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 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 1:1 to the electro-acupuncture group and 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 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.

Acupuncture for Olfactory Dysfunction in Infected COVID-19 Patients: Study Protocol for a Single Blind, Randomized, Sham-Controlled Clinical Trial

“…The placebo needle (SAC group) looks like a real acupuncture needle and appears to penetrate the skin like a real acupuncture needle. It will be applied at the real acupuncture points with the same stimulation modality except that the needles are only adhered to the skin by a small plastic ring instead of being inserted and the stimulation will be a "pseudo stimulation", which will be given by connecting the needle to an incorrect output socket of the electrical acupuncture stimulation instrument [9]. Therefore, the patients cannot visually detect sham or active acupuncture procedure.…”