Neuropathy, Paraneoplastic
Conditions
Keywords
neuropathy,paraneoplastic, paraneoplastic peripheral neuropathy, pain, hyperalgesia
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.
Interventions
DEVICEMC-5A
45 minutes daily x 10 treatments (given over the course of 2 weeks)
DRUGSham device
Sham therapy daily x 45 minutes for 10 treatments (given over course of 2 weeks)
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mechanical Visual Analog Scale (mVAS) Using Quantitative Sensory Pain Testing (QSPT) | Baseline, Visit 1 (Day 1), Vist 10 (Day 10), and End of Study (Week 12, +/- 2 weeks) | 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
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | Up to 3 months | The number of participants experiencing adverse events, as defined by CTCAE |
Countries
United States
Participant flow
Recruitment details
This study enrolled patients from May 2011 through May 2012 at a large research university.
Participants by arm
| Arm | Count |
|---|---|
| Sham Device Sham therapy device to area of painful chemotherapy induced peripheral neuropathy (CIPN) for 45 minutes daily x 10 days
Sham device: Sham therapy daily x 45 minutes for 10 treatments (given over course of 2 weeks) | 7 |
| MC-5A Treatment MC-5A therapy to the area of painful CIPN for 45 minutes daily for a total of 10 days.
MC-5A: 45 minutes daily x 10 treatments (given over the course of 2 weeks) | 7 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Event not related to subject | 1 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Sham Device | MC-5A Treatment | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 4 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 3 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 7 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 7 Participants | 14 Participants |
| Region of Enrollment United States | 7 participants | 7 participants | 14 participants |
| Sex: Female, Male Female | 5 Participants | 3 Participants | 8 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 7 |
| other Total, other adverse events | 4 / 7 | 4 / 7 |
| serious Total, serious adverse events | 1 / 7 | 0 / 7 |
Outcome results
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.
Time frame: Baseline, Visit 1 (Day 1), Vist 10 (Day 10), and End of Study (Week 12, +/- 2 weeks)
Population: The number analyzed differs per row as some participants dropped out or did not receive all 10 treatments. For example, on the Sham Device arm, only 4 participants were treated on day 10 but 5 returned for the final visit. Because this was a pilot study, all participant data was analyzed and is included here.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham Device | Change in Mechanical Visual Analog Scale (mVAS) Using Quantitative Sensory Pain Testing (QSPT) | Visit 1 (Day 1) | 5.14 Millimeters | Standard Deviation 29.1 |
| Sham Device | Change in Mechanical Visual Analog Scale (mVAS) Using Quantitative Sensory Pain Testing (QSPT) | Visit 10 (Day 10) | 1.25 Millimeters | Standard Deviation 2.5 |
| Sham Device | Change in Mechanical Visual Analog Scale (mVAS) Using Quantitative Sensory Pain Testing (QSPT) | End of Study (Week 12, +/- 2 weeks) | -11.2 Millimeters | Standard Deviation 5.36 |
| MC-5A Treatment | Change in Mechanical Visual Analog Scale (mVAS) Using Quantitative Sensory Pain Testing (QSPT) | Visit 1 (Day 1) | -2.00 Millimeters | Standard Deviation 17 |
| MC-5A Treatment | Change in Mechanical Visual Analog Scale (mVAS) Using Quantitative Sensory Pain Testing (QSPT) | Visit 10 (Day 10) | 6.76 Millimeters | Standard Deviation 24.7 |
| MC-5A Treatment | Change in Mechanical Visual Analog Scale (mVAS) Using Quantitative Sensory Pain Testing (QSPT) | End of Study (Week 12, +/- 2 weeks) | 3.80 Millimeters | Standard Deviation 3.42 |
Secondary
Adverse Events
The number of participants experiencing adverse events, as defined by CTCAE
Time frame: Up to 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sham Device | Adverse Events | 4 participants |
| MC-5A Treatment | Adverse Events | 4 participants |