Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
14 participants
INTERVENTIONAL
2011-04-30
2012-09-30
Brief Summary
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The purpose of this study is to determine if patients with painful CIPN will have a decrease in pain scores after treatment with the MC-5A device.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Sham device
Sham therapy device to area of painful chemotherapy induced peripheral neuropathy (CIPN) for 45 minutes daily x 10 days
Sham device
Sham therapy daily x 45 minutes for 10 treatments (given over course of 2 weeks)
MC-5A treatment
MC-5A therapy to the area of painful CIPN for 45 minutes daily for a total of 10 days.
MC-5A
45 minutes daily x 10 treatments (given over the course of 2 weeks)
Interventions
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MC-5A
45 minutes daily x 10 treatments (given over the course of 2 weeks)
Sham device
Sham therapy daily x 45 minutes for 10 treatments (given over course of 2 weeks)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* pain must be present for minimum of 6 months
* must be able to read/understand English
* stable analgesics regimens allowed (no change for past 7 days)
Exclusion Criteria
* pregnant women
* patients unable to wean off anti-epileptics
* patients currently receiving chemotherapy known to cause peripheral neuropathy
* patients with pacemakers or implanted defibrillators
* patients with vena cava or aneurysm clips
* patients with a history of epilepsy
18 Years
ALL
No
Sponsors
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University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Tony Campbell
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
Countries
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Related Links
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University of Wisconsin Carbone Cancer Center
Other Identifiers
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2010-0361
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2012-00075
Identifier Type: REGISTRY
Identifier Source: secondary_id
A534260
Identifier Type: OTHER
Identifier Source: secondary_id
SMPH\MEDICINE\HEM-ONC
Identifier Type: OTHER
Identifier Source: secondary_id
OS10328
Identifier Type: -
Identifier Source: org_study_id
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