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MC-5A for Chemotherapy Induced Peripheral Neuropathy

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ClinicalTrials.gov Identifier: NCT01261780
Recruitment Status : Completed
First Posted : December 16, 2010
Results First Posted : November 6, 2017
Last Update Posted : December 2, 2019
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Neuropathy, Paraneoplastic
Interventions Device: MC-5A
Drug: Sham device
Enrollment 14
Recruitment Details This study enrolled patients from May 2011 through May 2012 at a large research university.
Pre-assignment Details  
Arm/Group Title Sham Device MC-5A Treatment
Hide Arm/Group Description

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 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)

Period Title: Overall Study
Started 7 7
Completed 5 5
Not Completed 2 2
Reason Not Completed
Withdrawal by Subject             1             0
Event not related to subject             1             2
Arm/Group Title Sham Device MC-5A Treatment Total
Hide Arm/Group Description

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 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 of all reporting groups
Overall Number of Baseline Participants 7 7 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 14 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
  85.7%
3
  42.9%
9
  64.3%
>=65 years
1
  14.3%
4
  57.1%
5
  35.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 14 participants
Female
5
  71.4%
3
  42.9%
8
  57.1%
Male
2
  28.6%
4
  57.1%
6
  42.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 14 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
7
 100.0%
7
 100.0%
14
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 14 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
7
 100.0%
7
 100.0%
14
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants 7 participants 14 participants
7 7 14
1.Primary Outcome
Title Change in Mechanical Visual Analog Scale (mVAS) Using Quantitative Sensory Pain Testing (QSPT)
Hide Description

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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Sham Device MC-5A Treatment
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 7 6
Mean (Standard Deviation)
Unit of Measure: Millimeters
Visit 1 (Day 1) Number Analyzed 7 participants 6 participants
5.14  (29.1) -2.00  (17.0)
Visit 10 (Day 10) Number Analyzed 4 participants 5 participants
1.25  (2.50) 6.76  (24.7)
End of Study (Week 12, +/- 2 weeks) Number Analyzed 5 participants 6 participants
-11.2  (5.36) 3.80  (3.42)
2.Secondary Outcome
Title Adverse Events
Hide Description The number of participants experiencing adverse events, as defined by CTCAE
Time Frame Up to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sham Device MC-5A Treatment
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 7 7
Measure Type: Number
Unit of Measure: participants
4 4
Time Frame Adverse event data were collected for up to 3 months.
Adverse Event Reporting Description This study uses the CTCAE v.4 definition of adverse event, which does not differ from the clinicaltrials.gov definitions.
 
Arm/Group Title Sham Device MC-5A Treatment
Hide Arm/Group Description

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 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)

All-Cause Mortality
Sham Device MC-5A Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)      0/7 (0.00%)    
Hide Serious Adverse Events
Sham Device MC-5A Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/7 (14.29%)      0/7 (0.00%)    
Gastrointestinal disorders     
Small intestinal obstruction  1  1/7 (14.29%)  1 0/7 (0.00%)  0
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sham Device MC-5A Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/7 (57.14%)      4/7 (57.14%)    
Gastrointestinal disorders     
Diarrhea  1  1/7 (14.29%)  1 0/7 (0.00%) 
General disorders     
Fatigue  1  0/7 (0.00%)  1/7 (14.29%)  2
Gait disturbance  1  0/7 (0.00%)  1/7 (14.29%)  1
Non-cardiac chest pain  1  0/7 (0.00%)  1/7 (14.29%)  1
Pain  1  1/7 (14.29%)  1 2/7 (28.57%)  3
Psychiatric disorders     
Anxiety  1  0/7 (0.00%)  1/7 (14.29%)  1
Skin and subcutaneous tissue disorders     
Pruritus  1  1/7 (14.29%)  1 0/7 (0.00%) 
Skin, Other - Scratch in area by knee  1  1/7 (14.29%)  1 0/7 (0.00%) 
Skin, Other - Basel Cell Cancer Removed  1  0/7 (0.00%)  1/7 (14.29%)  1
Skin, Other - Redness at site of electrode pads (1 hr post treatment)  1  1/7 (14.29%)  1 0/7 (0.00%) 
Vascular disorders     
Hypertension  1  3/7 (42.86%)  3 1/7 (14.29%)  1
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
The small sample size is subject to type II error. The estimated effect size for MC5A is high: the company estimates 100% of patients will respond. Thus our power calculations suggested a small sample could still detect a difference.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Toby Campbell
Organization: University of Wisconsin Carbone Cancer Center
Phone: 608-263-3962
EMail: tcc@medicine.wisc.edu
Layout table for additonal information
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01261780    
Other Study ID Numbers: OS10328
2010-0361 ( Other Identifier: Institutional Review Board )
NCI-2012-00075 ( Registry Identifier: NCI Trial ID )
A534260 ( Other Identifier: UW Madison )
SMPH\MEDICINE\HEM-ONC ( Other Identifier: UW Madison )
First Submitted: December 9, 2010
First Posted: December 16, 2010
Results First Submitted: June 20, 2017
Results First Posted: November 6, 2017
Last Update Posted: December 2, 2019