Abstract
BackgroundColorectal 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/designThis 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 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).DiscussionThe 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 registrationClinicaltrials.gov, NCT03582423. Registered on 11 July 2018.
Highlights
Colorectal cancer is the most common cancer in Hong Kong
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
4b) Setting and context of treatment, including instructions to practitioners, and information and explanations to patients: Chinese Medicine Clinic cum Training and Research Centre Patients will be informed about acupuncture treatment in the study as follows: “in this study, acupoints for CINP will be used based on related reports and clinical experience of our investigators.”
Summary
This single-blinded, randomized, controlled, efficacy clinical trial aims at evaluating the efficacy and safety of acupuncture in chemotherapy-induced peripheral neuropathy (CIPN) in patients with colorectal cancer in Hong Kong. If the outcome from this study shows improvement in CIPN, it is hoped that further large-scale studies, perhaps with the combination of Chinese herbal medicine and in different types of cancer, could be conducted. Selection is not based on syndrome differentiation in Chinese medicine theory, which in other words, may result in over-simplification in treatment choice. This single-blinded, randomized, controlled clinical trial will be conducted to evaluate the efficacy and safety of acupuncture on CIPN in Hong Kong. Thirty-three patients are under treatment and recruitment will be completed in December 2019
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