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

Not Applicable

• Conditions: Electro-acupuncture; Chemotherapy-induced Nausea and Vomiting
• Interventions: Other: Single points PC6; Other: Matching points PC6+CV12

• Registration Number: NCT03061396
• Lead Sponsor: Tianjin University of Traditional Chinese Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-05
• Study Start: 2017-02-17
• Study First Submitted QC: 2017-02-17
• Study First Posted: 2017-02-23
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-08
• Last Update Posted: 2018-02-09
• Primary Completion: 2018-04-28
• Study Completion: 2018-05-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 208

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electroacupuncture Single point	Single points PC6	Single point PC6 means there is only one acupoint to be chosen: Neiguan(PC6)
Electroacupuncture Matching points	Matching points PC6+CV12	There are three acupoints to be chosen:Bilateral Neiguan(PC6)and Zhongwan(CV12)

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Tianjin University of TCM; 🇨🇳 Tianjin, Tianjin, China