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Comparative Effect Study Between Distal-proximal Point Association and Local Distribution Point Association in Chemotherapy-induced Nausea and Vomiting

Primary Purpose

Chemotherapy-induced Nausea and Vomiting

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
only antiemetic (Ramosetron, Tropisetron and dexamethasone)
Matching points ST36+CV12 plus antiemetic drug
Matching points PC6+CV12 plus antiemetic drug
Matching points CV13+CV12 plus 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 Chemotherapy-induced Nausea and Vomiting focused on measuring 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

Active Comparator

Experimental

Experimental

Experimental

Arm Label

only antiemetic

Matching points ST36+CV12

Matching points PC6+CV12

Matching points CV3+CV12

Arm Description

The participants in the control group received standard antiemetic alone. Standard antiemetic for all groups is based on American Society of Clinical Oncology cClinical pPractice gGuideline. The 5-hydroxytryptamine-3 (5-HT3) antagonist (Ramosetron, Tropisetron) and dexamethasone are administered before the chemotherapy treatment.

Outcomes

Primary Outcome Measures

the frequency of Nausea and Vomiting
the extent of Nausea and Vomiting
Rhodes Index of Nausea, Vomiting and Retching

Secondary Outcome Measures

the condition of constipation and diarrhea
gastric electrical activity (electrogastrogram)
the life quality of the patients
the Anxiety and Depression of the patients

Full Information

First Posted
May 19, 2015
Last Updated
June 22, 2015
Sponsor
Tianjin University of Traditional Chinese Medicine
Collaborators
National Basic Research Program, China
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1. Study Identification

Unique Protocol Identification Number
NCT02478047
Brief Title
Comparative Effect Study Between Distal-proximal Point Association and Local Distribution Point Association in Chemotherapy-induced Nausea and Vomiting
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
September 2016 (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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to clarify whether distal-proximal point association is more effective than partial match point association 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
Chemotherapy-induced Nausea and Vomiting
Keywords
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
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
only antiemetic
Arm Type
Active Comparator
Arm Description
The participants in the control group received standard antiemetic alone. Standard antiemetic for all groups is based on American Society of Clinical Oncology cClinical pPractice gGuideline. The 5-hydroxytryptamine-3 (5-HT3) antagonist (Ramosetron, Tropisetron) and dexamethasone are administered before the chemotherapy treatment.
Arm Title
Matching points ST36+CV12
Arm Type
Experimental
Arm Title
Matching points PC6+CV12
Arm Type
Experimental
Arm Title
Matching points CV3+CV12
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
only antiemetic (Ramosetron, Tropisetron and dexamethasone)
Intervention 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.And plus antiemetic drug as the comparator group.
Intervention Type
Other
Intervention Name(s)
Matching points ST36+CV12 plus antiemetic drug
Intervention Description
Choose both Zusanli(ST36) 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.And plus antiemetic drug as the comparator group.
Intervention Type
Other
Intervention Name(s)
Matching points PC6+CV12 plus antiemetic drug
Intervention Description
Choose both Neiguan(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.And plus antiemetic drug as the comparator group.
Intervention Type
Other
Intervention Name(s)
Matching points CV13+CV12 plus antiemetic drug
Intervention Description
Choose both Shangwan(CV13) 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.And plus antiemetic drug as the comparator group.
Primary Outcome Measure Information:
Title
the frequency of Nausea and Vomiting
Time Frame
3 weeks
Title
the extent of Nausea and Vomiting
Time Frame
3 weeks
Title
Rhodes Index of Nausea, Vomiting and Retching
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
the condition of constipation and diarrhea
Time Frame
3 weeks
Title
gastric electrical activity (electrogastrogram)
Time Frame
3 weeks
Title
the life quality of the patients
Time Frame
3 weeks
Title
the Anxiety and Depression of the patients
Time Frame
3 weeks
Other Pre-specified Outcome Measures:
Title
the number of blood cells
Description
the number of WBC,RBC,hemoglobin,PLT,the percents of GRA,LYM
Time Frame
3 weeks
Title
cardial electrical activity
Time Frame
3 weeks
Title
hepatic function
Description
The Outcome Measures will be assessed by blood, the metrics of ALT,AST,TBIL is IU/L,IU/L,and μmol/L.
Time Frame
3 weeks
Title
other adverse effect during the chemotherapy
Time Frame
3 weeks
Title
renal function
Description
The Outcome Measures will be assessed by blood, the metrics of BUN,Scr is mmol/L and μmol/L.
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
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guo Yi, Doc
Phone
13920921016
Email
tjutcmacupuncture@163.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
27821107
Citation
Gao L, Chen B, Zhang Q, Zhao T, Li B, Sha T, Zou J, Guo Y, Pan X, Guo Y. Acupuncture with different acupoint combinations for chemotherapy-induced nausea and vomiting: study protocol for a randomized controlled trial. BMC Complement Altern Med. 2016 Nov 8;16(1):441. doi: 10.1186/s12906-016-1425-1.
Results Reference
derived

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Comparative Effect Study Between Distal-proximal Point Association and Local Distribution Point Association in Chemotherapy-induced Nausea and Vomiting

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