The Different Effectiveness of Single Acupoint vs Matching Acupoints in Chemotherapy-induced Nausea and Vomiting：A Multicenter, Randomized, Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- Complete Control rates of Nausea and Vomiting
研究概览
简要总结
The purpose of this study is to clarify whether the matching acupoints are more effective than a single point by electro-acupuncture in the management of chemotherapy-induced nausea and vomiting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be diagnosed as cancer and need to accept chemotherapy
- •The score of Karnofsky ≥70
- •Patients of either gender and age 18 years to 80 years
- •Patients receiving chemotherapy both outpatients and inpatients
- •Patients receiving chemotherapy regime with high risk of causing vomiting: cisplatin ≥60 mg/m2, or joint chemotherapy regime of Anthracyclines (Adriamycin≥ 40 mg/ m2 or epirubicin≥60 mg/m2), Dacarbazine or Carboplatin（area under the curve greater than 5mg/ml/min）
- •Life expectancy > 6 months
排除标准
- •To receive radiotherapy and chemotherapy
- •Gastrointestinal tumors
- •Patients with serious liver disease or abnormal hepatorenal function (Aspartate Aminotransferase, Alanine Aminotransferase , and Total Bilirubin are 3 times more than normal, blood urea nitrogen and Cr are 2 times more than normal)
- •Presence of cardiac pacemaker
- •Inflammatory skin reaction
- •Nausea and/or vomiting resulting from opioids or metabolic imbalance (electrolytic disturbances)
- •Patients unable to provide self-care or communication
- •Nausea and/or vomiting resulting from mechanical risk factors (i.e.,intestinal obstruction)
- •Patients with brain metastases or symptoms of intracranial hypertension
- •Nausea and/or vomiting resulting from other diseases(i.e.,sympathetic cervical dispositions, Meniere's syndrome)
- •Women in pregnant and lactating period
- •Refusal to sign informed consent, rejection of randomization into intervention groups.
研究组 & 干预措施
Electroacupuncture Single point
Single point PC6 means there is only one acupoint to be chosen: Neiguan(PC6)
干预措施: Single points PC6 (Other)
Electroacupuncture Matching points
There are three acupoints to be chosen:Bilateral Neiguan(PC6)and Zhongwan(CV12)
干预措施: Matching points PC6+CV12 (Other)
结局指标
主要结局
Complete Control rates of Nausea and Vomiting
时间窗: 6weeks
There is no emetic episodes, no rescue therapy, and no significant nausea from first day of antiemetic therapy to 5th day.
Complete Response rates of Vomiting
时间窗: 6weeks
There is no emetic episodes and no rescue therapy on first day of antiemetic therapy and second day to 5th day.
Nausea and Vomiting visual analogic scale (VAS)
时间窗: 6weeks
次要结局
- Electrogastrogram(3weeks)
- the grading of constipation ,diarrhea and decrease in appetite(3weeks)
- Tcm Gastro-intestinal evaluation(3weeks)
- Hospital Anxiety and Depression Scale(3weeks)
- Functional Assessment of Cancer Treatment - General scale4.0(3weeks)
研究者
Yi Guo
Professor
Tianjin University of Traditional Chinese Medicine