The Comparative Study on the Effectiveness of Single Acupoint and Matching Acupoints.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- the frequency 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
- Single (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 older than 18 years
- •Patients receiving chemotherapy both outpatients and inpatients
- •Patients receiving chemotherapy either the first or multiple cycle, but the patient will be taken in only one time
- •To receive chemotherapy containing cisplatin(DDP≥75mg/m2) or joint chemotherapy programmes of Anthracyclines(Adriamycin≥40mg/m2 or epirubicin≥60mg/m2)
- •Life expectancy≥ 6 months
- •Willing to participate in the study and be randomized into one of the four study groups.
排除标准
- •To receive radiotherapy and chemotherapy
- •Gastrointestinal tumors
- •Patients with serious liver disease or abnormal hepatorenal function (AST,ACT, and TBIL are 3 times more than normal, BUN and Cr are 2 times more than normal)
- •Presence of cardiac pacemaker
- •Active skin infection
- •Nausea and/or vomiting resulting from opioids or metabolic imbalance (electrolyte disturbances)
- •Patients unable to provide self-care or communication
- •Nausea and/or vomiting resulting from mechanical risk factors (i.e., intestinal obstruction)
- •Brain metastases
- •Women in pregnant and lactating period
研究组 & 干预措施
Single point PC6
choose single point: Neiguan(PC6).Neiguan(PC6): On the anterior aspect of the forearm,between the tendons of the palmaris longus and the flexor carpi radialis, 2 B-cun proximal to the palmar wrist crease.Manipulating until achieving a "de Qi" sensation, then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA. The operation lasts for 30 min. The treatment is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.
干预措施: single point Neiguan(PC6) plus antiemetic drug (Other)
Single point CV12
choose another single point Zhongwan（CV12）. Zhongwan(CV12): On the upper abdomen, 4 B-cun superior to the centre of the umbilicus, on the anterior median line. Manipulating until achieving a "de Qi" sensation, then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatment is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.
干预措施: single point Zhongwan(CV12) plus antiemetic drug (Other)
Matching points PC6+CV12
Choose both Neiguan point(PC6) and Zhongwan point(CV12). Manipulating until achieving a "de Qi" sensation, then the needles are connected through a electro-acupuncture apparatus, the positive poles are linked to the needle, and the reference poles are located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA. The operation lasts for 30 min. The treatment is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.
干预措施: matching points Neiguan(PC6) and Zhongwan(CV12) plus antiemetic drug (Other)
only antiemetic
The control group will receive standard antiemetic alone. Standard antiemetic for all groups is based on American Society of Clinical Oncology clinical practice guideline. 5-hydroxytryptamine-3 (5-HT3) antagonist (Ramosetron, Tropisetron) and dexamethasone are supplied from the first day of chemotherapy, and lasting for 3-5 days.
干预措施: only antiemetic drug (Drug)
结局指标
主要结局
the frequency of Nausea and Vomiting
时间窗: 6days
次要结局
- the grading of constipation and diarrhea(3 weeks)
- electrogastrogram(3 weeks)
- the assessment of quality of life(3 weeks)
- the assessment of Anxiety and Depression(3 weeks)
研究者
Yi Guo
the Dean of Acupuncture and Moxibustion College
Tianjin University of Traditional Chinese Medicine