Trial Outcomes & Findings for MC-5A for Chemotherapy Induced Peripheral Neuropathy (NCT NCT01261780)

Last Updated: 2019-12-02

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

14 participants

Primary outcome timeframe

Baseline, Visit 1 (Day 1), Vist 10 (Day 10), and End of Study (Week 12, +/- 2 weeks)

Results posted on

2019-12-02

Participant Flow

This study enrolled patients from May 2011 through May 2012 at a large research university.

Participant milestones

Participant milestones
Measure	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)	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)
Overall Study STARTED	7	7
Overall Study COMPLETED	5	5
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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)	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)
Overall Study Withdrawal by Subject	1	0
Overall Study Event not related to subject	1	2

Baseline Characteristics

MC-5A for Chemotherapy Induced Peripheral Neuropathy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sham Device n=7 Participants 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)	MC-5A Treatment n=7 Participants 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)	Total n=14 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants	7 participants n=7 Participants	14 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Sham Device n=7 Participants 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)	MC-5A Treatment n=6 Participants 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)
Change in Mechanical Visual Analog Scale (mVAS) Using Quantitative Sensory Pain Testing (QSPT) Visit 1 (Day 1)	5.14 Millimeters Standard Deviation 29.1	-2.00 Millimeters Standard Deviation 17.0
Change in Mechanical Visual Analog Scale (mVAS) Using Quantitative Sensory Pain Testing (QSPT) Visit 10 (Day 10)	1.25 Millimeters Standard Deviation 2.50	6.76 Millimeters Standard Deviation 24.7
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	3.80 Millimeters Standard Deviation 3.42

SECONDARY outcome

Timeframe: Up to 3 months

The number of participants experiencing adverse events, as defined by CTCAE

Outcome measures

Outcome measures
Measure	Sham Device n=7 Participants 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)	MC-5A Treatment n=7 Participants 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)
Adverse Events	4 participants	4 participants

Adverse Events

Sham Device

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

MC-5A Treatment

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sham Device n=7 participants at risk 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)	MC-5A Treatment n=7 participants at risk 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)
Gastrointestinal disorders Small intestinal obstruction	14.3% 1/7 • Number of events 1 • Adverse event data were collected for up to 3 months. This study uses the CTCAE v.4 definition of adverse event, which does not differ from the clinicaltrials.gov definitions.	0.00% 0/7 • Adverse event data were collected for up to 3 months. This study uses the CTCAE v.4 definition of adverse event, which does not differ from the clinicaltrials.gov definitions.

Other adverse events

Other adverse events
Measure	Sham Device n=7 participants at risk 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)	MC-5A Treatment n=7 participants at risk 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)
Psychiatric disorders Anxiety	0.00% 0/7 • Adverse event data were collected for up to 3 months. This study uses the CTCAE v.4 definition of adverse event, which does not differ from the clinicaltrials.gov definitions.	14.3% 1/7 • Number of events 1 • Adverse event data were collected for up to 3 months. This study uses the CTCAE v.4 definition of adverse event, which does not differ from the clinicaltrials.gov definitions.
Gastrointestinal disorders Diarrhea	14.3% 1/7 • Number of events 1 • Adverse event data were collected for up to 3 months. This study uses the CTCAE v.4 definition of adverse event, which does not differ from the clinicaltrials.gov definitions.	0.00% 0/7 • Adverse event data were collected for up to 3 months. This study uses the CTCAE v.4 definition of adverse event, which does not differ from the clinicaltrials.gov definitions.
General disorders Fatigue	0.00% 0/7 • Adverse event data were collected for up to 3 months. This study uses the CTCAE v.4 definition of adverse event, which does not differ from the clinicaltrials.gov definitions.	14.3% 1/7 • Number of events 2 • Adverse event data were collected for up to 3 months. This study uses the CTCAE v.4 definition of adverse event, which does not differ from the clinicaltrials.gov definitions.
General disorders Gait disturbance	0.00% 0/7 • Adverse event data were collected for up to 3 months. This study uses the CTCAE v.4 definition of adverse event, which does not differ from the clinicaltrials.gov definitions.	14.3% 1/7 • Number of events 1 • Adverse event data were collected for up to 3 months. This study uses the CTCAE v.4 definition of adverse event, which does not differ from the clinicaltrials.gov definitions.
Vascular disorders Hypertension	42.9% 3/7 • Number of events 3 • Adverse event data were collected for up to 3 months. This study uses the CTCAE v.4 definition of adverse event, which does not differ from the clinicaltrials.gov definitions.	14.3% 1/7 • Number of events 1 • Adverse event data were collected for up to 3 months. This study uses the CTCAE v.4 definition of adverse event, which does not differ from the clinicaltrials.gov definitions.
General disorders Non-cardiac chest pain	0.00% 0/7 • Adverse event data were collected for up to 3 months. This study uses the CTCAE v.4 definition of adverse event, which does not differ from the clinicaltrials.gov definitions.	14.3% 1/7 • Number of events 1 • Adverse event data were collected for up to 3 months. This study uses the CTCAE v.4 definition of adverse event, which does not differ from the clinicaltrials.gov definitions.
General disorders Pain	14.3% 1/7 • Number of events 1 • Adverse event data were collected for up to 3 months. This study uses the CTCAE v.4 definition of adverse event, which does not differ from the clinicaltrials.gov definitions.	28.6% 2/7 • Number of events 3 • Adverse event data were collected for up to 3 months. This study uses the CTCAE v.4 definition of adverse event, which does not differ from the clinicaltrials.gov definitions.
Skin and subcutaneous tissue disorders Pruritus	14.3% 1/7 • Number of events 1 • Adverse event data were collected for up to 3 months. This study uses the CTCAE v.4 definition of adverse event, which does not differ from the clinicaltrials.gov definitions.	0.00% 0/7 • Adverse event data were collected for up to 3 months. This study uses the CTCAE v.4 definition of adverse event, which does not differ from the clinicaltrials.gov definitions.
Skin and subcutaneous tissue disorders Skin, Other - Scratch in area by knee	14.3% 1/7 • Number of events 1 • Adverse event data were collected for up to 3 months. This study uses the CTCAE v.4 definition of adverse event, which does not differ from the clinicaltrials.gov definitions.	0.00% 0/7 • Adverse event data were collected for up to 3 months. This study uses the CTCAE v.4 definition of adverse event, which does not differ from the clinicaltrials.gov definitions.
Skin and subcutaneous tissue disorders Skin, Other - Basel Cell Cancer Removed	0.00% 0/7 • Adverse event data were collected for up to 3 months. This study uses the CTCAE v.4 definition of adverse event, which does not differ from the clinicaltrials.gov definitions.	14.3% 1/7 • Number of events 1 • Adverse event data were collected for up to 3 months. This study uses the CTCAE v.4 definition of adverse event, which does not differ from the clinicaltrials.gov definitions.
Skin and subcutaneous tissue disorders Skin, Other - Redness at site of electrode pads (1 hr post treatment)	14.3% 1/7 • Number of events 1 • Adverse event data were collected for up to 3 months. This study uses the CTCAE v.4 definition of adverse event, which does not differ from the clinicaltrials.gov definitions.	0.00% 0/7 • Adverse event data were collected for up to 3 months. This study uses the CTCAE v.4 definition of adverse event, which does not differ from the clinicaltrials.gov definitions.

Additional Information

Toby Campbell

University of Wisconsin Carbone Cancer Center

Phone: 608-263-3962

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place