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

Tianjin University of Traditional Chinese Medicine

Status: Unknown

Conditions: Chemotherapy-induced Nausea and Vomiting; Electro-acupuncture

Treatments: Other: Single points PC6; Other: Matching points PC6+CV12

Study type: Interventional

Funder types: Other

Identifiers

NCT03061396

2014CB543201-03

Details and patient eligibility

About

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.

Enrollment: 208 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Be diagnosed as cancer and need to accept chemotherapy
2. The score of Karnofsky ≥70
3. Patients of either gender and age 18 years to 80 years
4. Patients receiving chemotherapy both outpatients and inpatients
5. 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）
6. Life expectancy > 6 months

Exclusion criteria

1. To receive radiotherapy and chemotherapy
2. Gastrointestinal tumors
3. 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)
4. Presence of cardiac pacemaker
5. Inflammatory skin reaction
6. Nausea and/or vomiting resulting from opioids or metabolic imbalance (electrolytic disturbances)
7. Patients unable to provide self-care or communication
8. Nausea and/or vomiting resulting from mechanical risk factors (i.e.,intestinal obstruction)
9. Patients with brain metastases or symptoms of intracranial hypertension
10. Nausea and/or vomiting resulting from other diseases(i.e.,sympathetic cervical dispositions, Meniere's syndrome)
11. Women in pregnant and lactating period
12. Refusal to sign informed consent, rejection of randomization into intervention groups.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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208 participants in 2 patient groups

Electroacupuncture Single point

Experimental group

Description:

Single point PC6 means there is only one acupoint to be chosen: Neiguan(PC6)

Treatment:

Other: Single points PC6

Electroacupuncture Matching points

Experimental group

Description:

There are three acupoints to be chosen:Bilateral Neiguan(PC6)and Zhongwan(CV12)

Treatment:

Other: Matching points PC6+CV12