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criskorea@korea.kr
  • Status : Approved
    • First Submitted Date : 2012/07/30
    • Registered Date : 2012/08/17
    • Last Updated Date : 2013/02/10
Background Information
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
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  
- Address  
- Telephone  
Data Monitoring Committee    
Contact Details
3.Contact Details  
Contact Person for Principal Investigator / Scientific Queries
- Name Sun-mi Choi 
- Title Doctor 
- Telephone  
- Affiliation Korea Institute of Oriental Medicine 
- Address  
Contact Person for Public Queries
- Name Joo-Hee Kim 
- Title Doctor 
- Telephone  
- Affiliation Korea Institute of Oriental Medicine 
- Address  
Contact Person for Updating Information
- Name Joo-Hee Kim 
- Title Doctor 
- Telephone  
- Affiliation Korea Institute of Oriental Medicine 
- Address  
Status
4. Status 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 Site Kyung Hee University Oriental Medicine Hospital at Gangdong 
- Recruitment Status Recruiting  
- Date of First Enrollment 2012-09-06 , Actual
Recruitment Status by Participating Study Site 2 
- Name of Study Site Dongguk University Ilsan Hospital 
- Recruitment Status Recruiting  
- Date of First Enrollment 2012-09-04 , Actual
Source of Monetary / Material Support 정보
5. Source of Monetary/Material Support  
Source of Monetary/Material Support1 
- Organization Name Korea Institute of Oriental Medicine 
- Organization Type Research Institute  
- Project ID KE1204 
Sponsor Organization
6. Sponsor Organization  
Sponsor Organization 1 
- Organization Name Korea Institute of Oriental Medicine 
- Organization Type Research Institute  
Study Summary
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 정보
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
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  
Condition(s)/Problem(s) * Diseases of the nervous system
 
Rare Disease No
Inclusion
Criteria
Gender Both 
Age 18 Year ~ 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
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
11. Study Results and Publication
Result Registerd  
Sharing of Study Data Information
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement Not provided at time of Registration