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Research: LI and COLLEAGUES,
Listed in Issue 261
Abstract
LI and COLLEAGUES, 1. Beijing Hospital of Traditional Chinese Medicine affiliated with Capital Medical University, No. 23, Back Road of Art Gallery, Dong Cheng District, Beijing, 100010, China; 2. Beijing University of Chinese Medicine, No. 11, Bei San Huan Dong Lu, Chaoyang District, Beijing, 100029, China; 3. Beijing Hospital of Traditional Chinese Medicine affiliated with Capital Medical University, No. 23, Back Road of Art Gallery, Dong Cheng District, Beijing, 100010, China. wangxiaomin_bhtcm@126.com. describe a multicenter, randomized, sham-controlled prospective clinical trial to study the clinical efficacy of acupuncture for the treatment of chemotherapy-induced nausea and vomiting (CINV) in cancer patients.
Background
Chemotherapy-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.
Methodology
This 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.
Results
Conclusion
The results of this trial will provide clinical evidence for the effect and safety of acupuncture for CINV. Trial Registrations: ISRCTN Registry identifier: ISRCTN13287728 ). Registered on 28 February 2015. ClinicalTrials.gov identifier: NCT02369107 . Registered on 17 February 2015.
References
Li QW1,2, Yu MW1, Yang GW1, Wang XM3, Wang H1, Zhang CX1, Xue N1, Xu WR1, Fu Q1, Yang Z1, Yang L1. Effect of acupuncture in prevention and treatment of chemotherapy-induced nausea and vomiting in patients with advanced cancer: study protocol for a randomized controlled trial. Trials. 18(1):185. Apr 20 2017. doi: 10.1186/s13063-017-1927-2.Bower JE1, Crosswell AD, Stanton AL, Crespi CM, Winston D, Arevalo J, Ma J, Cole SW, Ganz PA. Mindfulness meditation for younger breast cancer survivors: a randomized controlled trial. Cancer. 121(8):1231-40. Apr 15 2015. doi: 10.1002/cncr.29194. Epub Dec 23 2014. Erratum in Cancer.121(11):1910. Jun 1 2015
