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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

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    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
    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
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    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
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    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
  • 4. Status

    Status Information - 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
    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 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Korea Institute of Oriental Medicine
    Organization Type Research Institute
    Project ID KE1204
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Korea Institute of Oriental Medicine
    Organization Type Research Institute
  • 7. Study Summary

    Study Summary Information
    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.
  • 8. Study Design

    Study Design Information - 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
    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. 
  • 9. Subject Eligibility

    Subject Eligibility Information
    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
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    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
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement Not provided at time of Registration
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