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
CRIS Registration Number |
KCT0000506 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Multi-center Number of center : 2 | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Korea Institute of Oriental Medicine |
Organization Type | Research Institute |
Project ID | KE1204 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Korea Institute of Oriental Medicine |
Organization Type | Research Institute |
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. |
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8. Study Design
Study Type | Interventional Study |
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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
Condition(s)/Problem(s) |
* (G00-G99)Diseases of the nervous system (G62.0)Drug-induced polyneuropathy |
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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)
Type of Primary Outcome | /Safety/Efficacy | |
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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
Result Registered |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Not provided at time of Registration |
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