Phase 2
N=14
MC-5A for Chemotherapy Induced Peripheral Neuropathy
Neuropathy, Paraneoplastic
Bottom Line
View on ClinicalTrials.gov: NCT01261780 ↗Enrolled (actual)
14
Serious AEs
7.1%
Results posted
Nov 2017
Primary outcome: Primary: Change in Mechanical Visual Analog Scale (mVAS) Using Quantitative Sensory Pain Testing (QSPT) — 5.14; -2.00; 1.25; 6.76 Millimeters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MC-5A (Device); Sham device (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mechanical Visual Analog Scale (mVAS) Using Quantitative Sensory Pain Testing (QSPT) |
5.14; -2.00; 1.25; 6.76; -11.2; 3.80 | — |
| SECONDARY Adverse Events |
4; 4 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01261780). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.