Acupuncture for Chemical Therapy Induced Nausea and Vomiting: a Cross-over Trail
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- NCI nausea and vomiting rating scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of cancer
- •Must receive cancer chemotherapy containing cisplatin
- •Able to complete at least two continuous chemotherapy treatment cycles
- •Karnofsky performance status grade ≥60
- •Must use 5-TH receptor antagonists as an antiemetic drug in the chemotherapy duration
排除标准
- •Concurrent neoplasms or illness that induces nausea independent of chemotherapy
- •Receiving radiotherapy
- •Received acupuncture treatments for other conditions less than 4 weeks before chemotherapy treatment
- •Severe infection
- •Severe heart, liver, kidney and brain diseases
- •Unconsciousness
- •Psychosis
- •Language barriers
- •Cardiac pacemaker
- •Radiotherapy or hormone therapy during chemotherapy treatments
结局指标
主要结局
NCI nausea and vomiting rating scale
时间窗: day1-8 on each study period
次要结局
- Rhodes Scale(day1-5 on each study period)
- Acupuncture Expectancy Scale (AES)(day 1, 3, 5 on each study period)
- global assessment on effectiveness by patients (VAS)(day 5 on each study period)
- patients' confidence towards acupuncture treatment(VAS)(day 1,5 on each study period)
- global satisfaction for acupuncture treatments(day 5 on each study period)
研究者
Yutong Fei
Associate research fellow
Beijing University of Chinese Medicine