The Effect of Acupuncture in Chemotherapy-induced Nausea and Vomiting

Study Overview
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Brief Summary
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Nausea and vomiting are the most common symptoms experienced by cancer patients after chemotherapy. Some patients have to endure such unpleasant symptoms even after using of antiemetic or anti-vomiting medications.The purpose of this study is to assess the therapeutic effects and safety of acupuncture for chemotherapy-induced nausea and vomiting on patients with malignancy

Official Title
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A Multi-center,Randomized Controlled Clinical Trial: the Effect of Acupuncture in Prevention and Treatment of Chemotherapy-induced Nausea and Vomiting on Patients With Malignancy

Conditions
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Chemotherapy-induced Nausea and Vomiting

Intervention / Treatment
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* Other: Verum acupuncture and medicine
* Other: Sham acupuncture and medicine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with definite pathological diagnosis of lung cancer, breast cancer, and gynecological cancer.They haven't receive any chemotherapy or radiotherapy treatment for three months prior to join this study. Aged 18-75. Patients will receive chemotherapy treatment which included Cisplatin, anthracycline or taxane during the study period. ECOG score is between 0 and 2. The patients are diagnosed with insufficiency of spleen-qi and stomach-qi,reverse ascending of Stomach-Qi in traditional Chinese medicine theory. The expected lifetime of the patient is longer than 6 months. Patients willing to participate in the study and sign the consent form. Exclusion Criteria: Patients have serious disease in cardiovascular system ,liver system,kidney system, immune systems and hemopoietic system. Pregnant and lactating women. Patients have intractable vomiting caused by malignant brain metastases, intracranial hypertention, digestive tract obstruction, severe liver or Renal dysfunction, brain tumors, cerebrovascular disease, or other reasons. Patients with Coagulopathy, thrombocytopenia, or suffering from bleeding disorders. Patients have been definitely diagnosed with depression, anxiety disorders and psychosis Patients with Sepsis or Bacteremia. Patients have lymphedema in acupuncture stimulation area. Patients who are afraid of acupuncture stimulation or allergic to stainless steel needles can't participate in this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Verum acupuncture and medicine<br>Participants will receive acupuncture therapy 1 hour prior to chemotherapy administration ，6 hours after chemotherapy administration，and once acupuncture therapy on the following day2,3,4,5. The stimulation points are RN12,LR13(bilaterally), RN6, ST25(bilaterally), PC6(bilaterally), ST36(bilaterally). The acupuncture needle in ST36 and auxiliary point will be connected to form a circuit containing a SDZ-V stimulator for 30 min with a frequency of 2/100 Hz.They will receive 8mg Ondansetron Intravenously twice a day during the chemotherapy administration period (5 days in total). | Other: Verum acupuncture and medicine<br>* Participants will receive acupuncture therapy 1 hour prior to chemotherapy administration ，6 hours after chemotherapy administration，and once acupuncture therapy on the following day2,3,4,5. The stimulation points are RN12,LR13(bilaterally), RN6, ST25(bilaterally), PC6(bilaterally), ST36(bilaterally). The acupuncture needle in ST36 and auxiliary point will be connected to form a circuit containing a SDZ-V stimulator for 30 min with a frequency of 2/100 Hz. They will receive 8mg Ondansetron Intravenously twice a day during the chemotherapy administration period (5 days in total).<br>|
| Sham Comparator: Sham acupuncture and medicine<br>Participants will receive minimal acupuncture therapy at the same time as the intervention group .The stimulation points are not belong to traditional Chinese medicine.They will receive 8mg Ondansetron Intravenously twice a day during the chemotherapy administration period (5 days in total). | Other: Sham acupuncture and medicine<br>* Participants will receive minimal acupuncture therapy at the same time as the intervention group .The stimulation points are not belong to traditional Chinese medicine.They will receive 8mg Ondansetron Intravenously twice a day during the chemotherapy administration period (5 days in total).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in severity of nausea and vomiting at 21 days | The severity of nausea and vomiting will be assessed by the Common Terminology Criteria for Adverse Events (CTCAE) | It will be assessed at baseline,day1, day 2, day 3, day 7(±1)，day 10(±1), day 14(±1), day 21(±1).Patients have a daily questionnaire about nausea and vomiting during chemotherapy to record their feelings | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TCM symptoms scale | to evaluate TCM syndrome | It will be assessed at baseline, day3, day7(±1), day14(±1), day21(±1).Patients will be accessed with questionaire by doctors. | 
| ECOG score scale | to evaluate physical condition of patients | It will be assessed at baseline, day3, day7(±1), day14(±1), day21(±1).Patients will be accessed with questionaire by doctors. | 
| HADS | a questionnaire to access the anxiety levels of patients | It will be assessed at baseline, day3, day7(±1), day14(±1), day21(±1).Patients will be accessed with questionaire by doctors. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acupuncture, chemotherapy-induced nausea and vomiting