MC-5A for Chemotherapy Induced Peripheral Neuropathy

Treatment of Painful Chemotherapy -Induced Peripheral Neuropathy With the MC-5A Pain Therapy Medical Device, a Randomized, Double-Blind, Sham-Controlled Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Neuropathy, Paraneoplastic
• Intervention / Treatment: Drug: Sham device; Device: MC-5A

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
SHAM_COMPARATOR: Sham device; Sham therapy device to area of painful chemotherapy induced peripheral neuropathy (CIPN) for 45 minutes daily x 10 days	Drug: Sham device; Sham therapy daily x 45 minutes for 10 treatments (given over course of 2 weeks); Other Names: TRA-1
ACTIVE_COMPARATOR: MC-5A treatment; MC-5A therapy to the area of painful CIPN for 45 minutes daily for a total of 10 days.	Device: MC-5A; 45 minutes daily x 10 treatments (given over the course of 2 weeks); Other Names: Scrambler therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Visit 1 (Day 1), Vist 10 (Day 10), and End of Study (Week 12, +/- 2 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	The number of participants experiencing adverse events, as defined by CTCAE	Up to 3 months

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Tony Campbell, University of Wisconsin, Madison

Publications and helpful links

Helpful Links

• University of Wisconsin Carbone Cancer Center

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (ACTUAL): September 1, 2012
• Study Completion (ACTUAL): September 1, 2012

Study Registration Dates

• First Submitted: December 9, 2010
• First Submitted That Met QC Criteria: December 15, 2010
• First Posted (ESTIMATE): December 16, 2010

Study Record Updates

• Last Update Posted (ACTUAL): December 2, 2019
• Last Update Submitted That Met QC Criteria: November 14, 2019
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: pain; hyperalgesia; neuropathy,paraneoplastic; paraneoplastic peripheral neuropathy
• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms; Neoplasms by Site; Neuromuscular Diseases; Neurodegenerative Diseases; Nervous System Neoplasms; Paraneoplastic Syndromes, Nervous System; Paraneoplastic Syndromes; Polyneuropathies; Peripheral Nervous System Diseases; Paraneoplastic Polyneuropathy
• Other Study ID Numbers: OS10328; A534260 (Other Identifier: UW Madison); SMPH\MEDICINE\HEM-ONC (Other Identifier: UW Madison); 2010-0361 (OTHER: Institutional Review Board); NCI-2012-00075 (REGISTRY: NCI Trial ID)