Back to resultsMC-5A for Chemotherapy Induced Peripheral Neuropathy
Primary Purpose
Neuropathy, Paraneoplastic
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MC-5A
Sham device
Sponsored by
About this trial
This is an interventional treatment trial for Neuropathy, Paraneoplastic focused on measuring neuropathy,paraneoplastic, paraneoplastic peripheral neuropathy, pain, hyperalgesia
Eligibility Criteria
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
Sites / Locations
- University of Wisconsin Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
Sham device
MC-5A treatment
Arm Description
Sham therapy device to area of painful chemotherapy induced peripheral neuropathy (CIPN) for 45 minutes daily x 10 days
MC-5A therapy to the area of painful CIPN for 45 minutes daily for a total of 10 days.
Outcomes
Primary Outcome Measures
Change in Mechanical Visual Analog Scale (mVAS) Using Quantitative Sensory Pain Testing (QSPT)
Pain levels will be compared as measured by changes in mVAS, and quantified and tested for normal distribution. If normally distributed, parametric test (i.e., two-sample t-test) will be used; p-values <0.05 will be considered statistically significant. If changes in mVAS are not normally distributed, non-parametric testing such as Wilcoxon rank-sum will be performed. VAS is measured at 3 time points.
mVAS and deficits scale are used to obtain continuous quantitative information about positive and negative sensory phenomena during application of QSPT stimulation.
Patients provide rating of positive sensory phenomena using mVAS if the stimulus at the pain test site is increased or painful when compared to normal control site. Rating on mVAS is obtained by instructing the patient to pull out the mechanical scale with millimeters (looks like a slide ruler) to reflect intensity of any painful sensation on a scale of 0 - 10, with 10 being the worst. Score = Visit - Baseline.
Secondary Outcome Measures
Adverse Events
The number of participants experiencing adverse events, as defined by CTCAE
Full Information
NCT ID
NCT01261780
First Posted
December 9, 2010
Last Updated
November 14, 2019
Sponsor
University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT01261780
Brief Title
MC-5A for Chemotherapy Induced Peripheral Neuropathy
Official Title
Treatment of Painful Chemotherapy -Induced Peripheral Neuropathy With the MC-5A Pain Therapy Medical Device, a Randomized, Double-Blind, Sham-Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathy, Paraneoplastic
Keywords
neuropathy,paraneoplastic, paraneoplastic peripheral neuropathy, pain, hyperalgesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sham device
Arm Type
Sham Comparator
Arm Description
Sham therapy device to area of painful chemotherapy induced peripheral neuropathy (CIPN) for 45 minutes daily x 10 days
Arm Title
MC-5A treatment
Arm Type
Active Comparator
Arm Description
MC-5A therapy to the area of painful CIPN for 45 minutes daily for a total of 10 days.
Intervention Type
Device
Intervention Name(s)
MC-5A
Other Intervention Name(s)
Scrambler therapy
Intervention Description
45 minutes daily x 10 treatments (given over the course of 2 weeks)
Intervention Type
Drug
Intervention Name(s)
Sham device
Other Intervention Name(s)
TRA-1
Intervention Description
Sham therapy daily x 45 minutes for 10 treatments (given over course of 2 weeks)
Primary Outcome Measure Information:
Title
Change in Mechanical Visual Analog Scale (mVAS) Using Quantitative Sensory Pain Testing (QSPT)
Description
Pain levels will be compared as measured by changes in mVAS, and quantified and tested for normal distribution. If normally distributed, parametric test (i.e., two-sample t-test) will be used; p-values <0.05 will be considered statistically significant. If changes in mVAS are not normally distributed, non-parametric testing such as Wilcoxon rank-sum will be performed. VAS is measured at 3 time points.
mVAS and deficits scale are used to obtain continuous quantitative information about positive and negative sensory phenomena during application of QSPT stimulation.
Patients provide rating of positive sensory phenomena using mVAS if the stimulus at the pain test site is increased or painful when compared to normal control site. Rating on mVAS is obtained by instructing the patient to pull out the mechanical scale with millimeters (looks like a slide ruler) to reflect intensity of any painful sensation on a scale of 0 - 10, with 10 being the worst. Score = Visit - Baseline.
Time Frame
Baseline, Visit 1 (Day 1), Vist 10 (Day 10), and End of Study (Week 12, +/- 2 weeks)
Secondary Outcome Measure Information:
Title
Adverse Events
Description
The number of participants experiencing adverse events, as defined by CTCAE
Time Frame
Up to 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tony Campbell
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
12. IPD Sharing Statement
Links:
URL
https://cancer.wisc.edu/
Description
University of Wisconsin Carbone Cancer Center
Learn more about this trial
MC-5A for Chemotherapy Induced Peripheral Neuropathy
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