The Comparative Study on the Efficacy and Safety of Single Acupoint and Matching Acupoints

Study Overview
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Brief Summary
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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.

Official Title
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The Different Effectiveness of Single Acupoint vs Matching Acupoints in Chemotherapy-induced Nausea and Vomiting：A Multicenter, Randomized, Controlled Clinical Trial

Conditions
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Electro-acupuncture, Chemotherapy-induced Nausea and Vomiting

Intervention / Treatment
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* Other: Matching points PC6+CV12
* Other: Single points PC6


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electroacupuncture Single point<br>Single point PC6 means there is only one acupoint to be chosen: Neiguan(PC6) | Other: Single points PC6<br>* Choose Neiguan(PC6)of double upper limb.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 electrode.Frequency is 2/10 hertz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10 milliampere. And plus 5-hydroxytryptamine-3 (5-HT3) antagonist (Ramosetron, Tropisetron，Granisetron or Ondansetron) and dexamethasone.<br>|
| Experimental: Electroacupuncture Matching points<br>There are three acupoints to be chosen:Bilateral Neiguan(PC6)and Zhongwan(CV12) | Other: Matching points PC6+CV12<br>* Choose both Neiguan(PC6) and Zhongwan point(CV12).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 electrode.Frequency is 2/10 hertz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10 milliampere. And plus 5-hydroxytryptamine-3 (5-HT3) antagonist (Ramosetron, Tropisetron，Granisetron or Ondansetron) and dexamethasone.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Control rates of Nausea and Vomiting | There is no emetic episodes, no rescue therapy, and no significant nausea from first day of antiemetic therapy to 5th day. | 6weeks | 
| Complete Response rates of Vomiting | There is no emetic episodes and no rescue therapy on first day of antiemetic therapy and second day to 5th day. | 6weeks | 
| Nausea and Vomiting visual analogic scale (VAS) |  | 6weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tcm Gastro-intestinal evaluation |  | 3weeks | 
| the grading of constipation ,diarrhea and decrease in appetite | Number of participants with constipation ,diarrhea and decrease events as assessed by CTCAE v4.0 | 3weeks | 
| Electrogastrogram |  | 3weeks | 
| Hospital Anxiety and Depression Scale |  | 3weeks | 
| Functional Assessment of Cancer Treatment - General scale4.0 |  | 3weeks |