Acupuncture for Chemical Therapy Induced Nausea and Vomiting: a Cross-over Trail
Condition: Chemotherapy-induced Nausea and Vomiting
MeSH terms: Nausea; Vomiting
Study type: Interventional

Summary: 
      This is a randomized, controlled cross-over trial. The hypothesis of this study is that the
      differences in manual acupuncture manipulation can impact clinical effect though the
      acupuncturists follow the same needling regimen. In this study, acupuncturist 1 (clinical
      experience >15 years) and acupuncturist 2 (<5 years) will give treatments to cancer patients
      receiving cisplatin chemotherapy (n=36) for at least two continuous cycles, once per day, 5
      days per cycle. Acupuncturist 1 determines all the treatment regimens (selection of acupoints
      and methods of needling manipulation, needle retention time). Randomly, half of the patients
      will receive treatments from acupuncturist 1 in the first treatment cycle and from
      acupuncturist 2 in the second cycle; while the other half will be treated in other way round.
      There is a washout period (21 days) between two cycles. The needling manipulation of two
      acupuncturists will be measured objectively during treatments. The clinical effect will be
      measured by the control of vomiting and nausea during and after chemotherapy treatments.
    

Detailed description: 
      This is a randomized, controlled cross-over trial. The hypothesis of this study is that the
      differences in manual acupuncture manipulation can impact clinical effect though the
      acupuncturists follow the same needling regimen. In this study, acupuncturist 1 (clinical
      experience >15 years) and acupuncturist 2 (<5 years) will give treatments to cancer patients
      receiving cisplatin chemotherapy (n=36) for at least two continuous cycles, once per day, 5
      days per cycle. Acupuncturist 1 determines all the treatment regimens (selection of acupoints
      and methods of needling manipulation, needle retention time). Randomly, half of the patients
      will receive treatments from acupuncturist 1 in the first treatment cycle and from
      acupuncturist 2 in the second cycle; while the other half will be treated in other way round.
      There is a washout period (21 days) between two cycles. The needling manipulation of two
      acupuncturists will be measured objectively during treatments. The clinical effect will be
      measured by the control of vomiting and nausea during and after chemotherapy treatments. The
      manual manipulation of two acupuncturists will be recorded by device Acusensor.
    

Intervention name(s): Manual acupuncture implemented by acupuncturist 1; Manual acupuncture implemented by acupuncturist 2
Intervention type(s): Procedure; Procedure
Intervention description(s): Manual acupuncture once per day. Acupuncture treatment regimens (acupoints, needling methods, needle retention time) were decided by acupuncturist 1 according to the syndrome differentiation of patients. Acupuncturist 1 has to have more than 15 years of acupuncture clinical practice experience.; Manual acupuncture given by acupuncturist 2 once per day. Acupuncture treatment regimens (acupoints, needling methods, needle retention time) were decided by acupuncturist 1 according to the syndrome differentiation of patients. Acupuncturist 2 has to have less than 5 years of acupuncture clinical practice experience.
Other intervention name(s): Traditional manual acupuncture; Traditional acupuncture; Traditional manual acupuncture; Traditional acupuncture
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: chemotherapy; nausea; vomiting; cancer