• Qi-Wei Li, Ming-Wei Yu, Guo-Wang Yang, Xiao-Min Wang, Huan Wang, Chen-Xi Zhang, Na Xue, Wei-Ru Xu, Qi Fu, Zhong Yang, and Lin Yang.
• Beijing Hospital of Traditional Chinese Medicine affiliated with Capital Medical University, No. 23, Back Road of Art Gallery, Dong Cheng District, Beijing, 100010, China.
• Trials. 2017 Apr 20; 18 (1): 185.

BackgroundChemotherapy-induced nausea and vomiting (CINV) is one of the most common and distressing side effects in patients with cancer. The introduction and development of antiemetic drugs have significantly improved the ability of clinicians to control CINV, but it is not easy to translate to practical application, owing to financial issues, provider-related barriers, and patient factors. Nondrug therapies are needed to alleviate the symptoms of CINV. Acupuncture is an appropriate adjunctive treatment for CINV, but additional evidence is needed.Methods/DesignThis study is a multicenter, randomized, sham-controlled prospective clinical trial. A total of 136 participants will be randomly allocated into the intervention group (verum acupuncture) or the control group (sham acupuncture) in a 1:1 ratio. All treatment will be given for 5 days. Participants in both groups will receive acupuncture sessions twice on the first day of chemotherapy and once consecutively on the following 4 days. Each session takes approximately 30 minutes. The primary outcome measure will be the Common Terminology Criteria for Adverse Events to assess CINV. The secondary outcome measures will be the Eastern Cooperative Oncology Group score, Simplified Nutritional Appetite Questionnaire, and Hospital Anxiety and Depression scale. Safety will be assessed at each visit.DiscussionThe results of this trial will provide clinical evidence for the effect and safety of acupuncture for CINV.Trial RegistrationsISRCTN Registry identifier: ISRCTN13287728 ). Registered on 28 February 2015. ClinicalTrials.gov identifier: NCT02369107 . Registered on 17 February 2015.

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