Comparative Effect Study Between Distal-proximal Point Association and Local Distribution Point Association in Chemotherapy-induced Nausea and Vomiting

Study Overview
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Brief Summary
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The purpose of this study is to clarify whether distal-proximal point association is more effective than partial match point association by electro-acupuncture in the management of chemotherapy-induced nausea and vomiting .

Conditions
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Chemotherapy-induced Nausea and Vomiting

Intervention / Treatment
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* Drug: only antiemetic (Ramosetron, Tropisetron and dexamethasone)
* Other: Matching points ST36+CV12 plus antiemetic drug
* Other: Matching points PC6+CV12 plus antiemetic drug
* Other: Matching points CV13+CV12 plus antiemetic drug


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 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. Exclusion Criteria: 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

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: only antiemetic<br>The participants in the control group received standard antiemetic alone. Standard antiemetic for all groups is based on American Society of Clinical Oncology cClinical pPractice gGuideline. The 5-hydroxytryptamine-3 (5-HT3) antagonist (Ramosetron, Tropisetron) and dexamethasone are administered before the chemotherapy treatment. | Drug: only antiemetic (Ramosetron, Tropisetron and dexamethasone)<br>* 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.And plus antiemetic drug as the comparator group.<br>|
| Experimental: Matching points ST36+CV12<br> | Other: Matching points ST36+CV12 plus antiemetic drug<br>* Choose both Zusanli(ST36) 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.And plus antiemetic drug as the comparator group.<br>|
| Experimental: Matching points PC6+CV12<br> | Other: Matching points PC6+CV12 plus antiemetic drug<br>* Choose both Neiguan(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.And plus antiemetic drug as the comparator group.<br>|
| Experimental: Matching points CV3+CV12<br> | Other: Matching points CV13+CV12 plus antiemetic drug<br>* Choose both Shangwan(CV13) 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.And plus antiemetic drug as the comparator group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the frequency of Nausea and Vomiting |  | 3 weeks | 
| the extent of Nausea and Vomiting |  | 3 weeks | 
| Rhodes Index of Nausea, Vomiting and Retching |  | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the condition of constipation and diarrhea |  | 3 weeks | 
| gastric electrical activity (electrogastrogram) |  | 3 weeks | 
| the life quality of the patients |  | 3 weeks | 
| the Anxiety and Depression of the patients |  | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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to Evaluate the Effectiveness of Acupucnture in the Management of Chemotherapy-induced Nausea and Vomiting