Acupuncture for Chemical Therapy Induced Nausea and Vomiting: a Cross-over Trail (ACTIN)
Primary Purpose
Chemotherapy-induced Nausea and Vomiting
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Manual acupuncture implemented by acupuncturist 1
Manual acupuncture implemented by acupuncturist 2
Sponsored by
About this trial
This is an interventional treatment trial for Chemotherapy-induced Nausea and Vomiting focused on measuring chemotherapy, nausea, vomiting, cancer
Eligibility Criteria
Inclusion Criteria:
- Confirmed diagnosis of cancer
- Must receive cancer chemotherapy containing cisplatin
- Able to complete at least two continuous chemotherapy treatment cycles
- Karnofsky performance status grade ≥60
- Must use 5-TH receptor antagonists as an antiemetic drug in the chemotherapy duration
Exclusion Criteria:
- Concurrent neoplasms or illness that induces nausea independent of chemotherapy
- Receiving radiotherapy
- Received acupuncture treatments for other conditions less than 4 weeks before chemotherapy treatment
- Severe infection
- Severe heart, liver, kidney and brain diseases
- Unconsciousness
- Psychosis
- Language barriers
- Cardiac pacemaker
- Radiotherapy or hormone therapy during chemotherapy treatments
Sites / Locations
- Xiyuan Hospital, China Academy of Chinese Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
A (Acupuncturist 1)
B (Acupuncturist 2)
Arm Description
Manual acupuncture implemented by acupuncturist 1 (clinical experience >15 years)
Manual acupuncture implemented by acupuncturist 2 (clinical experience < 5 years)
Outcomes
Primary Outcome Measures
NCI nausea and vomiting rating scale
Secondary Outcome Measures
Rhodes Scale
global assessment on effectiveness by patients (VAS)
patients' confidence towards acupuncture treatment(VAS)
global satisfaction for acupuncture treatments
Acupuncture Expectancy Scale (AES)
Full Information
NCT ID
NCT02127255
First Posted
April 29, 2014
Last Updated
April 14, 2016
Sponsor
Beijing University of Chinese Medicine
Collaborators
Xiyuan Hospital of China Academy of Chinese Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02127255
Brief Title
Acupuncture for Chemical Therapy Induced Nausea and Vomiting: a Cross-over Trail
Acronym
ACTIN
Official Title
Acupuncture for Chemical Therapy Induced Nausea and Vomiting: a Cross-over Trail
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing University of Chinese Medicine
Collaborators
Xiyuan Hospital of China Academy of Chinese Medical Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a randomized, controlled cross-over trial. The hypothesis of this study is that the differences in manual acupuncture manipulation can impact clinical effect though the acupuncturists follow the same needling regimen. In this study, acupuncturist 1 (clinical experience >15 years) and acupuncturist 2 (<5 years) will give treatments to cancer patients receiving cisplatin chemotherapy (n=36) for at least two continuous cycles, once per day, 5 days per cycle. Acupuncturist 1 determines all the treatment regimens (selection of acupoints and methods of needling manipulation, needle retention time). Randomly, half of the patients will receive treatments from acupuncturist 1 in the first treatment cycle and from acupuncturist 2 in the second cycle; while the other half will be treated in other way round. There is a washout period (21 days) between two cycles. The needling manipulation of two acupuncturists will be measured objectively during treatments. The clinical effect will be measured by the control of vomiting and nausea during and after chemotherapy treatments.
Detailed Description
This is a randomized, controlled cross-over trial. The hypothesis of this study is that the differences in manual acupuncture manipulation can impact clinical effect though the acupuncturists follow the same needling regimen. In this study, acupuncturist 1 (clinical experience >15 years) and acupuncturist 2 (<5 years) will give treatments to cancer patients receiving cisplatin chemotherapy (n=36) for at least two continuous cycles, once per day, 5 days per cycle. Acupuncturist 1 determines all the treatment regimens (selection of acupoints and methods of needling manipulation, needle retention time). Randomly, half of the patients will receive treatments from acupuncturist 1 in the first treatment cycle and from acupuncturist 2 in the second cycle; while the other half will be treated in other way round. There is a washout period (21 days) between two cycles. The needling manipulation of two acupuncturists will be measured objectively during treatments. The clinical effect will be measured by the control of vomiting and nausea during and after chemotherapy treatments. The manual manipulation of two acupuncturists will be recorded by device Acusensor.
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
chemotherapy, nausea, vomiting, cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A (Acupuncturist 1)
Arm Type
Active Comparator
Arm Description
Manual acupuncture implemented by acupuncturist 1 (clinical experience >15 years)
Arm Title
B (Acupuncturist 2)
Arm Type
Active Comparator
Arm Description
Manual acupuncture implemented by acupuncturist 2 (clinical experience < 5 years)
Intervention Type
Procedure
Intervention Name(s)
Manual acupuncture implemented by acupuncturist 1
Other Intervention Name(s)
Traditional manual acupuncture, Traditional acupuncture
Intervention Description
Manual acupuncture once per day. Acupuncture treatment regimens (acupoints, needling methods, needle retention time) were decided by acupuncturist 1 according to the syndrome differentiation of patients. Acupuncturist 1 has to have more than 15 years of acupuncture clinical practice experience.
Intervention Type
Procedure
Intervention Name(s)
Manual acupuncture implemented by acupuncturist 2
Other Intervention Name(s)
Traditional manual acupuncture, Traditional acupuncture
Intervention Description
Manual acupuncture given by acupuncturist 2 once per day. Acupuncture treatment regimens (acupoints, needling methods, needle retention time) were decided by acupuncturist 1 according to the syndrome differentiation of patients. Acupuncturist 2 has to have less than 5 years of acupuncture clinical practice experience.
Primary Outcome Measure Information:
Title
NCI nausea and vomiting rating scale
Time Frame
day1-8 on each study period
Secondary Outcome Measure Information:
Title
Rhodes Scale
Time Frame
day1-5 on each study period
Title
global assessment on effectiveness by patients (VAS)
Time Frame
day 5 on each study period
Title
patients' confidence towards acupuncture treatment(VAS)
Time Frame
day 1,5 on each study period
Title
global satisfaction for acupuncture treatments
Time Frame
day 5 on each study period
Title
Acupuncture Expectancy Scale (AES)
Time Frame
day 1, 3, 5 on each study period
Other Pre-specified Outcome Measures:
Title
patient communication satisfaction scale
Time Frame
day 5 on each study period
Title
Acupuncture related adverse events
Description
faintng during acupuncture treatment, sticking of needle, bleeding in the needling hole, broken needles
Time Frame
day 1-5 each study period
Title
Adverse events (not acupuncture treatment specified)
Time Frame
day 1-5 each study period
Title
Needling manipulation parameters
Description
Displacement Frequency (Hz) Displacement Amplitude (pk-pk) Rotation Frequency (Hz) Rotation Amplitude (pk-pk)
Time Frame
day 1-5 each study period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Confirmed diagnosis of cancer
Must receive cancer chemotherapy containing cisplatin
Able to complete at least two continuous chemotherapy treatment cycles
Karnofsky performance status grade ≥60
Must use 5-TH receptor antagonists as an antiemetic drug in the chemotherapy duration
Exclusion Criteria:
Concurrent neoplasms or illness that induces nausea independent of chemotherapy
Receiving radiotherapy
Received acupuncture treatments for other conditions less than 4 weeks before chemotherapy treatment
Severe infection
Severe heart, liver, kidney and brain diseases
Unconsciousness
Psychosis
Language barriers
Cardiac pacemaker
Radiotherapy or hormone therapy during chemotherapy treatments
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yutong Fei, MD
Organizational Affiliation
Beijing University of Chinese Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xiyuan Hospital, China Academy of Chinese Medical Sciences
City
Beijing
ZIP/Postal Code
100091
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Acupuncture for Chemical Therapy Induced Nausea and Vomiting: a Cross-over Trail
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