The Different Effectiveness of Single Acupoint（PC6 or CV12) vs Matching Acupoints(PC6 and CV12) in Chemotherapy-induced Nausea and Vomiting

to Evaluate the Effectiveness of Acupucnture in the Management of Chemotherapy-induced Nausea and Vomiting Clinical Trial

Official title:

The Comparative Study on the Effectiveness of Single Acupoint and Matching Acupoints.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02195908
• Other study ID #: 2014CB543201-01
• Status: Completed
• Phase: N/A
• Start date: August 2014
• Est. completion date: October 2015

Study information

• Verified date: October 2020
• Source: Tianjin University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: October 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Be diagnosed as cancer and need to accept chemotherapy.

2. The score of Karnofsky =70

3. Patients of either gender and older than 18 years

4. Patients receiving chemotherapy both outpatients and inpatients

5. Patients receiving chemotherapy either the first or multiple cycle, but the patient will be taken in only one time

6. To receive chemotherapy containing cisplatin(DDP=75mg/m2) or joint chemotherapy programmes of Anthracyclines(Adriamycin=40mg/m2 or epirubicin=60mg/m2)

7. Life expectancy= 6 months

8. Willing to participate in the study and be randomized into one of the four study groups.

Exclusion Criteria:

1. To receive radiotherapy and chemotherapy

2. Gastrointestinal tumors

3. 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)

4. Presence of cardiac pacemaker

5. Active skin infection

6. Nausea and/or vomiting resulting from opioids or metabolic imbalance (electrolyte 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. Brain metastases

10. Women in pregnant and lactating period

Related Conditions & MeSH terms

• Nausea
• to Evaluate the Effectiveness of Acupucnture in the Management of Chemotherapy-induced Nausea and Vomiting
• Vomiting

Intervention

Other:
• single point Neiguan(PC6) plus antiemetic drug

• single point Zhongwan(CV12) plus antiemetic drug

• matching points Neiguan(PC6) and Zhongwan(CV12) plus antiemetic drug

Drug:
• only antiemetic drug

Locations

Country	Name	City	State
China	Tianjin University of TCM	Tianjin	Tianjin

Sponsors (2)

Lead Sponsor	Collaborator
Tianjin University of Traditional Chinese Medicine	National Basic Research Program, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	blood routine examination		3 weeks
Other	electrocardiogram		3 weeks
Other	hepatic and renal function		3 weeks
Other	other adverse effect during the chemotherapy		3 weeks
Primary	the frequency of Nausea and Vomiting		6days
Secondary	the grading of constipation and diarrhea		3 weeks
Secondary	electrogastrogram		3 weeks
Secondary	the assessment of quality of life		3 weeks
Secondary	the assessment of Anxiety and Depression		3 weeks