Neuropathy, Paraneoplastic Clinical Trial
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
| Verified date | October 2017 |
| Source | University of Wisconsin, Madison |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 14 |
| Est. completion date | September 2012 |
| Est. primary completion date | September 2012 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Wisconsin Comprehensive Cancer Center | Madison | Wisconsin |
| Lead Sponsor | Collaborator |
|---|---|
| University of Wisconsin, Madison |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Adverse Events | The number of participants experiencing adverse events, as defined by CTCAE | Up to 3 months |