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MC-5A for Chemotherapy Induced Peripheral Neuropathy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01261780
First Posted: December 16, 2010
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Wisconsin, Madison
Results First Submitted: June 20, 2017  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study enrolled patients from May 2011 through May 2012 at a large research university.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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)


Participant Flow:   Overall Study
    Sham Device   MC-5A Treatment
STARTED   7   7 
COMPLETED   5   5 
NOT COMPLETED   2   2 
Withdrawal by Subject                1                0 
Event not related to subject                1                2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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)

Total Total of all reporting groups

Baseline Measures
   Sham Device   MC-5A Treatment   Total 
Overall Participants Analyzed 
[Units: Participants]
 7   7   14 
Age 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of Participants
     
Female      5  71.4%      3  42.9%      8  57.1% 
Male      2  28.6%      4  57.1%      6  42.9% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of 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) 
[Units: Participants]
Count of 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 
[Units: Participants]
     
United States   7   7   14 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Mechanical Visual Analog Scale (mVAS) Using Quantitative Sensory Pain Testing (QSPT)   [ Time Frame: Baseline, Visit 1 (Day 1), Vist 10 (Day 10), and End of Study (Week 12, +/- 2 weeks) ]

2.  Secondary:   Adverse Events   [ Time Frame: Up to 3 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Toby Campbell
Organization: University of Wisconsin Carbone Cancer Center
phone: 608-263-3962
e-mail: tcc@medicine.wisc.edu



Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01261780     History of Changes
Other Study ID Numbers: OS10328
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: November 6, 2017