Electroacupuncture for Chemotherapy-induced Peripheral Neuropathy: A Randomized, Patient-Assessor Blinded, Controlled Pilot Clinical Trial
Status :
Approved
First Submitted Date : 2012/07/30
Registered Date : 2012/08/17
Last Updated Date : 2013/07/11
Status :
Approved
First Submitted Date : 2012/07/30
Registered Date : 2012/08/17
Last Updated Date : 2013/07/11
Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
1. Background
CRIS Registration Number
KCT0000506
Unique Protocol ID
KE1204
Public/Brief Title
Electroacupuncture for Chemotherapy-induced Peripheral Neuropathy: A Randomized, Controlled Trial
Scientific Title
Electroacupuncture for Chemotherapy-induced Peripheral Neuropathy: A Randomized, Patient-Assessor Blinded, Controlled Pilot Clinical Trial
Acronym
MFDS Regulated Study
No
IND/IDE Protocol
No
Registered at Other Registry
No
Healthcare Benefit Approval Status
Institutional Review Board Information - Clinical research ethics review consisting of approval status, approval number, approval date, committee information, and data monitoring committee.
2. Institutional Review Board/Ethics Committee
Board Approval Status
Submitted approval
Board Approval Number
2012-01
Approval Date
2012-07-11
Institutional Review Board Name
Institutional Review Board of Oriental Hospital of Dongguk University Il San Oriental Hospital
Institutional Review Board Address
Institutional Review Board Telephone
Data Monitoring Committee
Contact Details Information - Contact Details Information consisting of Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Name of Contact Person for Updating Information, Title, Email, Telephone, Cellular Phone, Affiliation, Address.
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries
Name
Sun-mi
Choi
Title
Doctor
Telephone
+82-42-868-9485
Affiliation
Korea Institute of Oriental Medicine
Address
Contact Person for Public Queries
Name
Joo-Hee
Kim
Title
Doctor
Telephone
+82-42-223-4052
Affiliation
Korea Institute of Oriental Medicine
Address
Contact Person for Updating Information
Name
Joo-Hee
Kim
Title
Doctor
Telephone
+82-42-223-4052
Affiliation
Korea Institute of Oriental Medicine
Address
Status Information - Status Information consisting of Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt.
4. Status
Study Site
Multi-center
Number of center : 2
Overall Recruitment Status
Recruiting
Date of First Enrollment
2012-09-04
Actual
Target Number of Participant
40
Primary Completion Date
Study Completion Date
Recruitment Status by Participating Study Site 1
Name of Study
Kyung Hee University Oriental Medicine Hospital at Gangdong
Recruitment Status
Recruiting
Date of First Enrollment
2012-09-06
,
Recruitment Status by Participating Study Site 2
Name of Study
Dongguk University Ilsan Hospital
Recruitment Status
Recruiting
Date of First Enrollment
2012-09-04
,
Source of Monetary / Material Support Information - Source of Monetary / Material Support Information consisting of Organization Name, Organization Type, Project ID.
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support
Organization Name
Korea Institute of Oriental Medicine
Organization Type
Research Institute
Project ID
KE1204
Sponsor Organization Information - Sponsor Organization Information consisting of Organization Name, Organization Type.
6. Sponsor Organization
1. Sponsor Organization
Organization Name
Korea Institute of Oriental Medicine
Organization Type
Research Institute
Study Summary Information
7. Study Summary
Lay Summary
This study is a pilot randomized controlled trial whose participants are patients with chemotherapy-induced peripheral neuropathy. A parallel trial design was used to compare two groups: electroacupuncture group and sham group. Aim of this study is to evaluate feasibility for massive clinical research and make basic analysis of efficacy and safety of electroacupuncture treatment for treating chemotherapy-induced peripheral neuropathy.
Study Design Information - Study Design Information consisting of Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description.
8. Study Design
Study Type
Interventional Study
Study Purpose
Treatment
Phase
Not applicable
Intervention Model
Parallel
Blinding/Masking
Single
Blinded Subject
Subject, Outcome Accessor
Allocation
RCT
Intervention Type
Medical Device
Intervention Description
A study that compares treatment efficacy of electroacupuncture VS sham electroacupuncture in the treatment of chemotherapy-induced peripheral neuropathy.
Treatment regimen: 2 times/week for 4 weeks
Number of Arms
2
Arm 1
Arm Label
Electroacupuncture group
Target Number of Participant
20
Arm Type
Experimental
Arm Description
Electrocupuncture treatment 2 times/week for 4 weeks/ After inserting 0.25 * 40mm disposable sterile acupuncutre, retaining for 30 minutes with MIX of 2Hz/120Hz and 80% intensity of being able to bear through electroacupuncture device (PG-306 pulse generator, Suzuki Iryoki, Japan).
Arm 2
Arm Label
sham electroacupuncture group
Target Number of Participant
20
Arm Type
Sham comparator
Arm Description
Sham electrocupuncture treatment 2 times/week for 8 weeks/ The acupuncture is connected with electroacupuncture device and no electrical current is passed to needle, but the light of lamp is seen and the sound of the pulse generator is heard by the participants in the same with electroacupuncture group. Retaining for 30 minutes.
Subject Eligibility Information
9. Subject Eligibility
Condition(s)/Problem(s)
* (G00-G99)Diseases of the nervous system
(G62.0)Drug-induced polyneuropathy
Rare Disease
No
Inclusion Criteria
Gender
Both
Age
18Year~No Limit
Description
1. Males and females aged 18 years and older
2. Patients who had received or were currently receiving neurotoxic chemotherapy with a diagnosis of cancer
3. Symptoms of peripheral neuropathy of duration ≥ 1 month attributed to chemotherapy, and a score ≥ 4 out of 10 on the NRS scale.
4. No use of medications to prevent or treat neuropathy within 2 weeks or stable use had been made in their medications to prevent or treat neuropathy within 2 months before screening.
5. ECOG PS of 0-2
6. Life expectancy ≥ 6 months
7. Agreed with written informed consent
Exclusion Criteria
1. Pre-existing or history of peripheral neuropathy due to any cause other than chemotherapy (diabetes, peripheral vascular disease, HIV, alcohol, toxin, hereditary, nerve compression injuries, etc.)
2.Known hypersensitivity reaction after acupuncture treatment or inability to cooperate with acupuncture procedure
3. Received acupuncture, moxibustion, cupping or herbal medicine for peripheral neuropathy last 4 weeks
4. Cardiovascular disorder (e.g. arrhythmia) or using pacemaker
5. Pregnant, expecting pregnant or nursing women
6. Those who are not willing to comply with this study protocol
Healthy Volunteers
No
Outcome Measure(s) Information - Outcome Measure(s) Information consisting of Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint.
10. Outcome Measure(s)
Type of Primary Outcome
/Safety/Efficacy
Primary Outcome(s) 1
Outcome
EORTC QLQ-CIPN20
Timepoint
baseline, 2, 4, 8, 12 week
Secondary Outcome(s) 1
Outcome
11-point numerical rating scale (NRS)
Timepoint
at every visit
Secondary Outcome(s) 2
Outcome
Semmes Weinstein monofilaments test
Timepoint
baseline, 2, 4, 8, 12 week
Secondary Outcome(s) 3
Outcome
Nerve Conduction Study
Timepoint
baseline, 12 week
Secondary Outcome(s) 4
Outcome
EORTC QLQ-C30
Timepoint
baseline, 2, 4, 8, 12 week
Secondary Outcome(s) 5
Outcome
Patient Global Impression of Change (PGIC)
Timepoint
4, 8, 12 week
Secondary Outcome(s) 6
Outcome
Adverse events
Timepoint
at every visit
Study Results and Publication Information - Study Results and Publication Information consisting of Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary.
11. Study Results and Publication
Result Registered
Sharing of Study Data Information - Sharing of Study Data Information consisting of Sharing Statement, Time of Sharing, Way of Sharing.
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)