Back to resultsAcupuncture for Chemotherapy-Induced Nausea and Vomiting
Primary Purpose
Chemotherapy-induced Nausea and Vomiting
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
single point Zhongwan(CV12) plus antiemetic drug
single point Zusanli(ST36) plus antiemetic drug
Zusanli(ST36)and Zhongwan(CV12) plus antiemetic drug
only antiemetic drug
Sponsored by
About this trial
This is an interventional treatment trial for Chemotherapy-induced Nausea and Vomiting
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 he 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
Sites / Locations
- Tianjin University of Traditional Chinese Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
Single point CV12
Single point ST36
ST36+CV12 acupoints
only antiemetics
Arm Description
choose 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 treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days. Received routine antiemetic treatment.
choose another single point Zusanli（ST36）.Zusanli(ST36):On the anterior aspect of the leg, on the line connecting ST35 with ST41, 3 B-cun inferior to ST35，located on the tibialis anterior muscle..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 treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days. Received routine antiemetic treatment.
Choose both Zusanli(ST36) and Zhongwan（CV12）.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 treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days. Received routine antiemetic treatment.
The control group will receive standard antiemetics alone. Standard antiemetics for all groups are 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 chemtherapy,and lasting for 3-5days. If nausea and/or vomiting is persistent and failed to respond to the antiemetic treatment , based on the experience of each clinician, the other advanced 5-HT3 antagonist or a neurokinin 1 antagonist(NK-1) will be chosen.
Outcomes
Primary Outcome Measures
Percentage of Participants With Nausea
Percentage of participants with nausea was assessed by visual analog scale (VAS) ranging from 0 (no nausea) to 10 (worst nausea). A score of 0 means no nausea for a portion of the patient's assessment.
Number of Times Vomiting Occurs After Chemotherapy
The number of times vomiting occurs after chemotherapy for each participant during 0-120 hours. The evaluator completed daily diaries for each time point.
Rhodes Index of Nausea, Vomiting and Retching
The RINVR scale has 8 items . The scale divides the occurrence of nausea , vomiting , and retching within 12 hours of tumor chemotherapy patients into 5 grades , which are scored from 0 to 4 points . The lower the score , the better . The RINVR scale can be divided into three dimensions : symptom experience time , symptom frequency and symptom severity .
Percentage of Participants With Nausea and Number of Times of Vomiting Occurs After Chemotherapy
Rhodes Index of Nausea, Vomiting and Retching was replaced by percentage of participants with nausea (assessed by VAS) and number of times of vomiting occurs which were recorded in the first and second primary outcome.
Secondary Outcome Measures
Grading of Constipation and Diarrhea
The grading of constipation and diarrhea.We deleted this evaluation method due to weak correlation.
Electrogastrogram
We deleted this evaluation method due to weak correlation.
the Assessment of Quality of Life
Assessed by the Functional Assessment of Cancer Treatment-General (FACT-G) .The FACT-G includes 27 items and is divided among 4 subscales: physical well-being (PWB), functional well-being (FWB), social/family well-being (SWB), and emotional well-being (EWB). The total FACT-G score ranges from 0 to 108 and is calculated by the sum of the subscales, with higher scores indicating greater functional status
the Assessment of Anxiety and Depression
Assessed by Hospital Anxiety and Depression Scale (HADS scale). It includes fourteen items, seven of which assess anxiety and the other seven assess depression (30). The total scores range from 0 to 21 for depression and anxiety, respectively, with higher scores indicating more depression and anxiety.
Full Information
NCT ID
NCT02195921
First Posted
July 17, 2014
Last Updated
January 21, 2021
Sponsor
Tianjin University of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02195921
Brief Title
Acupuncture for Chemotherapy-Induced Nausea and Vomiting
Official Title
Acupuncture for Chemotherapy-Induced Nausea and Vomiting: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tianjin University of Traditional Chinese Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to clarify whether the matching acupoints is more effective than a single point by electroacupuncture in the management of chemotherapy-induced nausea and vomiting .
Detailed Description
Patients were assigned to Four sessions of electroacupuncture(EA) at the CV12, ST36, CV12+ST36 acupoints or antiemetic therapy over 5 days. primary and secondary outcomes and Adverse Eventswill be assessed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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 CV12
Arm Type
Experimental
Arm Description
choose 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 treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days. Received routine antiemetic treatment.
Arm Title
Single point ST36
Arm Type
Experimental
Arm Description
choose another single point Zusanli（ST36）.Zusanli(ST36):On the anterior aspect of the leg, on the line connecting ST35 with ST41, 3 B-cun inferior to ST35，located on the tibialis anterior muscle..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 treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days. Received routine antiemetic treatment.
Arm Title
ST36+CV12 acupoints
Arm Type
Experimental
Arm Description
Choose both Zusanli(ST36) and Zhongwan（CV12）.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 treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days. Received routine antiemetic treatment.
Arm Title
only antiemetics
Arm Type
Active Comparator
Arm Description
The control group will receive standard antiemetics alone. Standard antiemetics for all groups are 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 chemtherapy,and lasting for 3-5days. If nausea and/or vomiting is persistent and failed to respond to the antiemetic treatment , based on the experience of each clinician, the other advanced 5-HT3 antagonist or a neurokinin 1 antagonist(NK-1) will be chosen.
Intervention Type
Other
Intervention Name(s)
single point Zhongwan(CV12) plus antiemetic drug
Intervention Description
All participants were supine in the hospital bed. A disposable sterile acupuncture needle (ø 0.30 × 40 mm, Hwato) was inserted vertically at approximately 20-30 mm until "De Qi" (sensation of soreness, numbness, distension, etc. around the acupoint) was reported by the participants. Then, the needle handle was clamped via a metal clip to connect to the positive electrode of the electric acupuncture apparatus (Huatuo, SDZ-V model, Suzhou Medical Appliance). Another reference electrode was placed 1 cm above the CV12 acupoints of the stimulation point, where no acupoints or meridians passed through. A dilatational wave at a frequency of 2/10 Hz and a current intensity at the highest level tolerated by the patient, with a maximum intensity no more than 10 mA, were used to deliver the EA stimulation. People in the intervention groups were offered a standardized 30-minute EA session once daily from the 1st day of the four-day chemotherapy cycle.
Intervention Type
Other
Intervention Name(s)
single point Zusanli(ST36) plus antiemetic drug
Intervention Description
A disposable sterile acupuncture needle (ø 0.30 × 40 mm, Hwato) was inserted vertically at approximately 20-30 mm until "De Qi" (sensation of soreness, numbness, distension, etc. around the acupoint) was reported by the participants. Then, the needle handle was clamped via a metal clip to connect to the positive electrode of the electric acupuncture apparatus (Huatuo, SDZ-V model, Suzhou Medical Appliance). Another reference electrode was placed 1cm below ST36 acupoints of the stimulation point, respectively, where no acupoints or meridians passed through. A dilatational wave at a frequency of 2/10 Hz and a current intensity at the highest level tolerated by the patient, with a maximum intensity no more than 10 mA, were used to deliver the EA stimulation. People in the intervention groups were offered a standardized 30-minute EA session once daily from the 1st day of the four-day chemotherapy cycle.
Intervention Type
Other
Intervention Name(s)
Zusanli(ST36)and Zhongwan(CV12) plus antiemetic drug
Intervention Description
Stimulating both Zusanli(ST36)and Zhongwan(CV12)
Intervention Type
Drug
Intervention Name(s)
only antiemetic drug
Intervention Description
received routine antiemetic treatment
Primary Outcome Measure Information:
Title
Percentage of Participants With Nausea
Description
Percentage of participants with nausea was assessed by visual analog scale (VAS) ranging from 0 (no nausea) to 10 (worst nausea). A score of 0 means no nausea for a portion of the patient's assessment.
Time Frame
5 days
Title
Number of Times Vomiting Occurs After Chemotherapy
Description
The number of times vomiting occurs after chemotherapy for each participant during 0-120 hours. The evaluator completed daily diaries for each time point.
Time Frame
5 days
Title
Rhodes Index of Nausea, Vomiting and Retching
Description
The RINVR scale has 8 items . The scale divides the occurrence of nausea , vomiting , and retching within 12 hours of tumor chemotherapy patients into 5 grades , which are scored from 0 to 4 points . The lower the score , the better . The RINVR scale can be divided into three dimensions : symptom experience time , symptom frequency and symptom severity .
Time Frame
5 days
Title
Percentage of Participants With Nausea and Number of Times of Vomiting Occurs After Chemotherapy
Description
Rhodes Index of Nausea, Vomiting and Retching was replaced by percentage of participants with nausea (assessed by VAS) and number of times of vomiting occurs which were recorded in the first and second primary outcome.
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Grading of Constipation and Diarrhea
Description
The grading of constipation and diarrhea.We deleted this evaluation method due to weak correlation.
Time Frame
5 days
Title
Electrogastrogram
Description
We deleted this evaluation method due to weak correlation.
Time Frame
5 days
Title
the Assessment of Quality of Life
Description
Assessed by the Functional Assessment of Cancer Treatment-General (FACT-G) .The FACT-G includes 27 items and is divided among 4 subscales: physical well-being (PWB), functional well-being (FWB), social/family well-being (SWB), and emotional well-being (EWB). The total FACT-G score ranges from 0 to 108 and is calculated by the sum of the subscales, with higher scores indicating greater functional status
Time Frame
5 days
Title
the Assessment of Anxiety and Depression
Description
Assessed by Hospital Anxiety and Depression Scale (HADS scale). It includes fourteen items, seven of which assess anxiety and the other seven assess depression (30). The total scores range from 0 to 21 for depression and anxiety, respectively, with higher scores indicating more depression and anxiety.
Time Frame
5 days
Other Pre-specified Outcome Measures:
Title
Blood Routine Examination
Description
We deleted this evaluation method due to weak correlation.
Time Frame
5 days
Title
Electrocardiogram
Description
We deleted this evaluation method due to weak correlation.
Time Frame
5 days
Title
Hepatic and Renal Function
Description
We deleted this evaluation method due to weak correlation.
Time Frame
5 days
Title
Other Adverse Effect During the Chemotherapy
Time Frame
5 days
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 he 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi Guo
Organizational Affiliation
Tianjin University of Traditional Chinese Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Tianjin University of Traditional Chinese Medicine
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
301617
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
29029639
Citation
Chen B, Guo Y, Zhao X, Gao LL, Li B, Zhao TY, Zhang QW, Zou JX, Li MY, Guo YM, Guo Y, Pan XF. Efficacy differences of electroacupuncture with single acupoint or matching acupoints for chemotherapy-induced nausea and vomiting: study protocol for a randomized controlled trial. Trials. 2017 Oct 13;18(1):477. doi: 10.1186/s13063-017-2186-y.
Results Reference
derived
Learn more about this trial
Acupuncture for Chemotherapy-Induced Nausea and Vomiting
We'll reach out to this number within 24 hrs