Back to resultsThe Comparative Study on the Efficacy and Safety of Single Acupoint and Matching Acupoints
Primary Purpose
Electro-acupuncture, Chemotherapy-induced Nausea and Vomiting
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Matching points PC6+CV12
Single points PC6
Sponsored by
About this trial
This is an interventional treatment trial for Electro-acupuncture
Eligibility Criteria
Inclusion Criteria:
- Be diagnosed as cancer and need to accept chemotherapy
- The score of Karnofsky ≥70
- Patients of either gender and age 18 years to 80 years
- Patients receiving chemotherapy both outpatients and inpatients
- 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）
- Life expectancy > 6 months
Exclusion Criteria:
- To receive radiotherapy and chemotherapy
- Gastrointestinal tumors
- 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)
- Presence of cardiac pacemaker
- Inflammatory skin reaction
- Nausea and/or vomiting resulting from opioids or metabolic imbalance (electrolytic disturbances)
- Patients unable to provide self-care or communication
- Nausea and/or vomiting resulting from mechanical risk factors (i.e.,intestinal obstruction)
- Patients with brain metastases or symptoms of intracranial hypertension
- Nausea and/or vomiting resulting from other diseases(i.e.,sympathetic cervical dispositions, Meniere's syndrome)
- Women in pregnant and lactating period
- Refusal to sign informed consent, rejection of randomization into intervention groups.
Sites / Locations
- Tianjin University of TCMRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Electroacupuncture Single point
Electroacupuncture Matching points
Arm Description
Single point PC6 means there is only one acupoint to be chosen: Neiguan(PC6)
There are three acupoints to be chosen:Bilateral Neiguan(PC6)and Zhongwan(CV12)
Outcomes
Primary Outcome Measures
Complete Control rates of Nausea and Vomiting
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
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)
Secondary Outcome Measures
Tcm Gastro-intestinal evaluation
the grading of constipation ,diarrhea and decrease in appetite
Number of participants with constipation ,diarrhea and decrease events as assessed by CTCAE v4.0
Electrogastrogram
Hospital Anxiety and Depression Scale
Functional Assessment of Cancer Treatment - General scale4.0
Full Information
NCT ID
NCT03061396
First Posted
February 5, 2017
Last Updated
February 8, 2018
Sponsor
Tianjin University of Traditional Chinese Medicine
Collaborators
National Basic Research Program, China, West China Hospital, Tianjin Medical University Cancer Institute and Hospital, Gansu Provincial Cancer Hospital, Henan Provincial People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03061396
Brief Title
The Comparative Study on the Efficacy and Safety of Single Acupoint and Matching Acupoints
Official Title
The Different Effectiveness of Single Acupoint vs Matching Acupoints in Chemotherapy-induced Nausea and Vomiting：A Multicenter, Randomized, Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 17, 2017 (Actual)
Primary Completion Date
April 28, 2018 (Anticipated)
Study Completion Date
May 28, 2018 (Anticipated)
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, West China Hospital, Tianjin Medical University Cancer Institute and Hospital, Gansu Provincial Cancer Hospital, Henan Provincial People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
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
Electro-acupuncture, Chemotherapy-induced Nausea and Vomiting
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
208 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Electroacupuncture Single point
Arm Type
Experimental
Arm Description
Single point PC6 means there is only one acupoint to be chosen: Neiguan(PC6)
Arm Title
Electroacupuncture Matching points
Arm Type
Experimental
Arm Description
There are three acupoints to be chosen:Bilateral Neiguan(PC6)and Zhongwan(CV12)
Intervention Type
Other
Intervention Name(s)
Matching points PC6+CV12
Intervention Description
Choose both Neiguan(PC6) and Zhongwan point(CV12).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 electrode.Frequency is 2/10 hertz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10 milliampere. And plus 5-hydroxytryptamine-3 (5-HT3) antagonist (Ramosetron, Tropisetron，Granisetron or Ondansetron) and dexamethasone.
Intervention Type
Other
Intervention Name(s)
Single points PC6
Intervention Description
Choose Neiguan(PC6)of double upper limb.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 electrode.Frequency is 2/10 hertz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10 milliampere. And plus 5-hydroxytryptamine-3 (5-HT3) antagonist (Ramosetron, Tropisetron，Granisetron or Ondansetron) and dexamethasone.
Primary Outcome Measure Information:
Title
Complete Control rates of Nausea and Vomiting
Description
There is no emetic episodes, no rescue therapy, and no significant nausea from first day of antiemetic therapy to 5th day.
Time Frame
6weeks
Title
Complete Response rates of Vomiting
Description
There is no emetic episodes and no rescue therapy on first day of antiemetic therapy and second day to 5th day.
Time Frame
6weeks
Title
Nausea and Vomiting visual analogic scale (VAS)
Time Frame
6weeks
Secondary Outcome Measure Information:
Title
Tcm Gastro-intestinal evaluation
Time Frame
3weeks
Title
the grading of constipation ,diarrhea and decrease in appetite
Description
Number of participants with constipation ,diarrhea and decrease events as assessed by CTCAE v4.0
Time Frame
3weeks
Title
Electrogastrogram
Time Frame
3weeks
Title
Hospital Anxiety and Depression Scale
Time Frame
3weeks
Title
Functional Assessment of Cancer Treatment - General scale4.0
Time Frame
3weeks
Other Pre-specified Outcome Measures:
Title
Number of Participants With Abnormal Laboratory Values
Description
the number of blood cells,serumAlanine aminotransferase,Aspertate，Aminotransferase,total bilirubin,Creatinine，blood sodium，blood potassium
Time Frame
6weeks
Title
cardial electrical activity
Time Frame
6weeks
Title
other adverse effect during the chemotherapy
Time Frame
6weeks
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 age 18 years to 80 years
Patients receiving chemotherapy both outpatients and inpatients
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）
Life expectancy > 6 months
Exclusion Criteria:
To receive radiotherapy and chemotherapy
Gastrointestinal tumors
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)
Presence of cardiac pacemaker
Inflammatory skin reaction
Nausea and/or vomiting resulting from opioids or metabolic imbalance (electrolytic disturbances)
Patients unable to provide self-care or communication
Nausea and/or vomiting resulting from mechanical risk factors (i.e.,intestinal obstruction)
Patients with brain metastases or symptoms of intracranial hypertension
Nausea and/or vomiting resulting from other diseases(i.e.,sympathetic cervical dispositions, Meniere's syndrome)
Women in pregnant and lactating period
Refusal to sign informed consent, rejection of randomization into intervention groups.
Facility Information:
Facility Name
Tianjin University of TCM
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300193
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guo Yi, Doc
Phone
13920921016
Email
tjutcmacupuncture@163.com
12. IPD Sharing Statement
Learn more about this trial
The Comparative Study on the Efficacy and Safety of Single Acupoint and Matching Acupoints
We'll reach out to this number within 24 hrs