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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
single point Neiguan(PC6) plus antiemetic drug
single point Zhongwan(CV12) plus antiemetic drug
matching points Neiguan(PC6) and Zhongwan(CV12) plus antiemetic drug
only antiemetic drug
Sponsored by
Tianjin University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for to Evaluate the Effectiveness of Acupucnture in the Management of Chemotherapy-induced Nausea and Vomiting

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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 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

Sites / Locations

  • Tianjin University of TCM

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Single point PC6

Single point CV12

Matching points PC6+CV12

only antiemetic

Arm Description

choose single point: Neiguan(PC6).Neiguan(PC6): On the anterior aspect of the forearm,between the tendons of the palmaris longus and the flexor carpi radialis, 2 B-cun proximal to the palmar wrist crease.Manipulating until achieving a "de Qi" sensation, then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is 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.

choose another single point Zhongwan（CV12）. Zhongwan(CV12): On the upper abdomen, 4 B-cun superior to the centre of the umbilicus, on the anterior median line. Manipulating until achieving a "de Qi" sensation, then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is 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.

Choose both Neiguan point(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.

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.

Outcomes

Primary Outcome Measures

the frequency of Nausea and Vomiting

Secondary Outcome Measures

the grading of constipation and diarrhea
electrogastrogram
the assessment of quality of life
the assessment of Anxiety and Depression

Full Information

First Posted
July 17, 2014
Last Updated
October 5, 2020
Sponsor
Tianjin University of Traditional Chinese Medicine
Collaborators
National Basic Research Program, China
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1. Study Identification

Unique Protocol Identification Number
NCT02195908
Brief Title
The Different Effectiveness of Single Acupoint（PC6 or CV12) vs Matching Acupoints(PC6 and CV12) in Chemotherapy-induced Nausea and Vomiting
Official Title
The Comparative Study on the Effectiveness of Single Acupoint and Matching Acupoints.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tianjin University of Traditional Chinese Medicine
Collaborators
National Basic Research Program, China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
to Evaluate the Effectiveness of Acupucnture in the Management of Chemotherapy-induced Nausea and Vomiting

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single point PC6
Arm Type
Experimental
Arm Description
choose single point: Neiguan(PC6).Neiguan(PC6): On the anterior aspect of the forearm,between the tendons of the palmaris longus and the flexor carpi radialis, 2 B-cun proximal to the palmar wrist crease.Manipulating until achieving a "de Qi" sensation, then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is 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.
Arm Title
Single point CV12
Arm Type
Experimental
Arm Description
choose another single point Zhongwan（CV12）. Zhongwan(CV12): On the upper abdomen, 4 B-cun superior to the centre of the umbilicus, on the anterior median line. Manipulating until achieving a "de Qi" sensation, then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is 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.
Arm Title
Matching points PC6+CV12
Arm Type
Experimental
Arm Description
Choose both Neiguan point(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.
Arm Title
only antiemetic
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
single point Neiguan(PC6) plus antiemetic drug
Intervention Type
Other
Intervention Name(s)
single point Zhongwan(CV12) plus antiemetic drug
Intervention Type
Other
Intervention Name(s)
matching points Neiguan(PC6) and Zhongwan(CV12) plus antiemetic drug
Intervention Type
Drug
Intervention Name(s)
only antiemetic drug
Primary Outcome Measure Information:
Title
the frequency of Nausea and Vomiting
Time Frame
6days
Secondary Outcome Measure Information:
Title
the grading of constipation and diarrhea
Time Frame
3 weeks
Title
electrogastrogram
Time Frame
3 weeks
Title
the assessment of quality of life
Time Frame
3 weeks
Title
the assessment of Anxiety and Depression
Time Frame
3 weeks
Other Pre-specified Outcome Measures:
Title
blood routine examination
Time Frame
3 weeks
Title
electrocardiogram
Time Frame
3 weeks
Title
hepatic and renal function
Time Frame
3 weeks
Title
other adverse effect during the chemotherapy
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Tianjin University of TCM
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300193
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
25963295
Citation
Chen B, Hu SX, Liu BH, Zhao TY, Li B, Liu Y, Li MY, Pan XF, Guo YM, Chen ZL, Guo Y. Efficacy and safety of electroacupuncture with different acupoints for chemotherapy-induced nausea and vomiting: study protocol for a randomized controlled trial. Trials. 2015 May 12;16:212. doi: 10.1186/s13063-015-0734-x.
Results Reference
derived

Learn more about this trial

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

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