Abstract
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.
Highlights
Chemotherapy-induced nausea and vomiting (CINV) is one of the most common and distressing side effects in patients with cancer
Patient-related variables that influence the risk of CINV include age, sex, history of low prior chronic alcohol intake, history of previous chemotherapyinduced emesis, and others [5]
Study design This study is a multicenter, randomized, shamcontrolled prospective clinical trial aimed at estimating the efficacy and safety of acupuncture on CINV by comparing a verum acupuncture group with a sham acupuncture group
Summary
Acupuncture, one of the major components of TCM, is deemed to be an available complementary therapy to relieve symptoms. We have presented the design of a randomized controlled trial of verum acupuncture compared with sham acupuncture Completion of this trial will contribute to verifying the efficacy of acupuncture for the treatment of CINV. Shallow insertion may lead to latent physiological effects to alleviate the symptoms In this trial, the sham points are selected to avoid meridians and acupoints, but we cannot rule out physiological effects from the control group design. The sham points are selected to avoid meridians and acupoints, but we cannot rule out physiological effects from the control group design Another limitation is that the research assistant and therapists are not blinded in this study.
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