MC-5A for Chemotherapy Induced Peripheral Neuropathy

NCT ID: NCT01261780

Last Updated: 2019-12-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-09-30

Brief Summary

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Painful chemotherapy induced peripheral neuropathy (CIPN) is a common complication of cancer therapy with few treatment options. CIPN is a complex side effect that varies between individuals and can be difficult to describe, difficult to treat and can significantly effect quality of life for patients.

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.

Detailed Description

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Conditions

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Neuropathy, Paraneoplastic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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

Group Type SHAM_COMPARATOR

Sham device

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

MC-5A

Intervention Type DEVICE

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)

Intervention Type DEVICE

Sham device

Sham therapy daily x 45 minutes for 10 treatments (given over course of 2 weeks)

Intervention Type DRUG

Other Intervention Names

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Scrambler therapy TRA-1

Eligibility Criteria

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Inclusion Criteria

* painful peripheral neuropathy resulting from chemotherapy
* 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

* painful peripheral neuropathy that is not the result of chemotherapy
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

Related Links

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https://cancer.wisc.edu/

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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