Acupuncture for Chemotherapy-Induced Nausea and Vomiting: A Randomized Clinical Trial
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
- Percentage of Participants With Nausea
研究概览
简要总结
The purpose of this study is to clarify whether the matching acupoints is more effective than a single point by electroacupuncture in the management of chemotherapy-induced nausea and vomiting .
详细描述
Patients were assigned to Four sessions of electroacupuncture(EA) at the CV12, ST36, CV12+ST36 acupoints or antiemetic therapy over 5 days. primary and secondary outcomes and Adverse Eventswill be assessed.
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 he 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 CV12
choose 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 treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days. Received routine antiemetic treatment.
干预措施: single point Zhongwan(CV12) plus antiemetic drug (Other)
Single point ST36
choose another single point Zusanli（ST36）.Zusanli(ST36):On the anterior aspect of the leg, on the line connecting ST35 with ST41, 3 B-cun inferior to ST35，located on the tibialis anterior muscle..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 treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days. Received routine antiemetic treatment.
干预措施: single point Zusanli(ST36) plus antiemetic drug (Other)
ST36+CV12 acupoints
Choose both Zusanli(ST36) and Zhongwan（CV12）.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 treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days. Received routine antiemetic treatment.
干预措施: Zusanli(ST36)and Zhongwan(CV12) plus antiemetic drug (Other)
only antiemetics
The control group will receive standard antiemetics alone. Standard antiemetics for all groups are 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 chemtherapy,and lasting for 3-5days. If nausea and/or vomiting is persistent and failed to respond to the antiemetic treatment , based on the experience of each clinician, the other advanced 5-HT3 antagonist or a neurokinin 1 antagonist(NK-1) will be chosen.
干预措施: only antiemetic drug (Drug)
结局指标
主要结局
Percentage of Participants With Nausea
时间窗: 5 days
Percentage of participants with nausea was assessed by visual analog scale (VAS) ranging from 0 (no nausea) to 10 (worst nausea). A score of 0 means no nausea for a portion of the patient's assessment.
Number of Times Vomiting Occurs After Chemotherapy
时间窗: 5 days
The number of times vomiting occurs after chemotherapy for each participant during 0-120 hours. The evaluator completed daily diaries for each time point.
Rhodes Index of Nausea, Vomiting and Retching
时间窗: 5 days
The RINVR scale has 8 items . The scale divides the occurrence of nausea , vomiting , and retching within 12 hours of tumor chemotherapy patients into 5 grades , which are scored from 0 to 4 points . The lower the score , the better . The RINVR scale can be divided into three dimensions : symptom experience time , symptom frequency and symptom severity .
Percentage of Participants With Nausea and Number of Times of Vomiting Occurs After Chemotherapy
时间窗: 5 days
Rhodes Index of Nausea, Vomiting and Retching was replaced by percentage of participants with nausea (assessed by VAS) and number of times of vomiting occurs which were recorded in the first and second primary outcome.
次要结局
- Grading of Constipation and Diarrhea(5 days)
- Electrogastrogram(5 days)
- the Assessment of Quality of Life(5 days)
- the Assessment of Anxiety and Depression(5 days)
研究者
Yi Guo
Dean of Traditional Chinese Medicine School
Tianjin University of Traditional Chinese Medicine