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

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, Lin Yang, 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, Lin Yang

Abstract

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.

Methods/design: 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.

Discussion: 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.

Keywords: Acupuncture; CTCAE; Chemotherapy-induced nausea and vomiting; Clinical research trial; ECOG; SNAQ; Sham acupuncture.

Figures

Fig. 1
Fig. 1
Project overview. The safety assessment comprises a routine blood test, routine urine test, routine feces test, kidney function test, liver function test, and electrocardiogram. CTCAE Common Terminology Criteria for Adverse Events (Chinese version), ECOG Eastern Cooperative Oncology Group score (Chinese version), SNAQ Simplified Nutritional Appetite Questionnaire, HADS Hospital Anxiety and Depression Scale (Chinese version)
Fig. 2
Fig. 2
The schedule of enrollment, interventions, and assessments. The safety assessment comprises a routine blood test, routine urine test, routine feces test, kidney function test, liver function test, and electrocardiogram. CTCAE Common Terminology Criteria for Adverse Events (Chinese version), ECOG Eastern Cooperative Oncology Group score (Chinese version), SNAQ Simplified Nutritional Appetite Questionnaire, HADS Hospital Anxiety and Depression Scale (Chinese version)

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