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Electrical Stimulation Pain Therapy in Treating Chronic Pain and Numbness Caused By Chemotherapy in Patients With Cancer

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.
 
ClinicalTrials.gov Identifier: NCT01196442
Recruitment Status : Completed
First Posted : September 8, 2010
Results First Posted : February 12, 2013
Last Update Posted : August 23, 2013
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions Cancer-related Problem/Condition
Neurotoxicity
Pain
Peripheral Neuropathy
Interventions Other: electrical stimulation pain therapy
Other: questionnaire administration
Enrollment 39
Recruitment Details Subjects were enrolled from 08/30/2010 through 06/11/2012 at a medical clinical
Pre-assignment Details No pre-assignment criteria
Arm/Group Title MC5A Calmare Therapy
Hide Arm/Group Description

Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.

electrical stimulation pain therapy : Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10

questionnaire administration : Brief Pain Inventory at baseline, weekly, then monthly for 3 months
Period Title: Overall Study
Started 39
Completed 39
Not Completed 0
Arm/Group Title MC5A Calmare Therapy
Hide Arm/Group Description

Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.

electrical stimulation pain therapy : Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10

questionnaire administration : Brief Pain Inventory at baseline, weekly, then monthly for 3 months
Overall Number of Baseline Participants 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants
<=18 years
0
   0.0%
Between 18 and 65 years
29
  74.4%
>=65 years
10
  25.6%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 39 participants
59  (0.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants
Female
23
  59.0%
Male
16
  41.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 39 participants
39
1.Primary Outcome
Title Change in Pain Score From Day 1 to Day 10
Hide Description

Change in Brief Pain Inventory (Now)Scale

1 (none) to 5 (complete interference)
Time Frame From day 1 to day 10
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I
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Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.

Electrical stimulation pain therapy: Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10

Questionnaire administration: Brief Pain Inventory at baseline, weekly, then monthly for 3 months
Overall Number of Participants Analyzed 39
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.3  (0.7)
2.Secondary Outcome
Title Effect of Electrical Stimulation Pain Therapy on Other Non-pain Symptoms at Day 1
Hide Description Chemotherapy-induced peripheral neuropathy (CIPN)-20. The CIPN-20 has 3 subscales: a sensory, motor, and autonomic subscale. There are 17 questions that are rated 0-not at all to 3-very much. Scales are summed. Final score ranges from 0-51, 0 as the best possible outcome and 51 as the worst.
Time Frame Day 1
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Hide Analysis Population Description
Participants at Day 1
Arm/Group Title MC5A Calmare Therapy
Hide Arm/Group Description:

Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.

electrical stimulation pain therapy : Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10

questionnaire administration : Brief Pain Inventory at baseline, weekly, then monthly for 3 months
Overall Number of Participants Analyzed 39
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
sensory symptoms 20.4129  (0.9114)
motor symptoms 15.6268  (0.7598)
3.Secondary Outcome
Title Use of Medications Including Morphine Oral Dose Equivalents, Anti-depressants, and Neuroleptics
Hide Description Record daily pain medication usage and convert all opioids to MOEDs (American Pain Society 2003). Compare the average daily use prior to day 1 to the average daily use day 30. Range is 0-none to 240-most
Time Frame From day 1 to day 30
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MC5A Calmare Therapy
Hide Arm/Group Description:

Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.

electrical stimulation pain therapy : Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10

questionnaire administration : Brief Pain Inventory at baseline, weekly, then monthly for 3 months
Overall Number of Participants Analyzed 39
Mean (Standard Deviation)
Unit of Measure: doses
28.9  (47.3)
4.Secondary Outcome
Title Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Day 10
Hide Description Chemotherapy-induced peripheral neuropathy (CIPN)-20. The CIPN-20 has 3 subscales: a sensory, motor, and autonomic subscale. There are 17 questions that are rated 0-not at all to 3-very much. Scales are summed. Final score ranges from 0-51, 0 as the best possible outcome and 51 as the worst.
Time Frame Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MC5A Calmare Therapy
Hide Arm/Group Description:

Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.

electrical stimulation pain therapy : Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10

questionnaire administration : Brief Pain Inventory at baseline, weekly, then monthly for 3 months
Overall Number of Participants Analyzed 33
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
sensory symptoms 17.8305  (0.9437)
motor symptoms 14.1815  (0.7878)
5.Secondary Outcome
Title Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Month 1
Hide Description Chemotherapy-induced peripheral neuropathy (CIPN)-20. The CIPN-20 has 3 subscales: a sensory, motor, and autonomic subscale. There are 17 questions that are rated 0-not at all to 3-very much. Scales are summed. Final score ranges from 0-51, 0 as the best possible outcome and 51 as the worst.
Time Frame month 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MC5A Calmare Therapy
Hide Arm/Group Description:

Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.

electrical stimulation pain therapy : Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10

questionnaire administration : Brief Pain Inventory at baseline, weekly, then monthly for 3 months
Overall Number of Participants Analyzed 33
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
snesory symptoms 16.5207  (0.9345)
motor symptoms 13.5443  (0.7797)
6.Secondary Outcome
Title Effect of Electric Stimulation Pain Therapy n Other Non-pain Symptoms at Month 2
Hide Description Chemotherapy-induced peripheral neuropathy (CIPN)-20. The CIPN-20 has 3 subscales: a sensory, motor, and autonomic subscale. There are 17 questions that are rated 0-not at all to 3-very much. Scales are summed. Final score ranges from 0-51, 0 as the best possible outcome and 51 as the worst.
Time Frame month 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MC5A Calmare Therapy
Hide Arm/Group Description:

Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.

electrical stimulation pain therapy : Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10

questionnaire administration : Brief Pain Inventory at baseline, weekly, then monthly for 3 months
Overall Number of Participants Analyzed 32
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
sensory symptoms 16.4723  (0.9480)
motor symptoms 13.3816  (0.7917)
7.Secondary Outcome
Title Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Month 3
Hide Description Chemotherapy-induced peripheral neuropathy (CIPN)-20. The CIPN-20 has 3 subscales: a sensory, motor, and autonomic subscale. There are 17 questions that are rated 0-not at all to 3-very much. Scales are summed. Final score ranges from 0-51, 0 as the best possible outcome and 51 as the worst.
Time Frame Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MC5A Calmare Therapy
Hide Arm/Group Description:

Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.

electrical stimulation pain therapy : Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10

questionnaire administration : Brief Pain Inventory at baseline, weekly, then monthly for 3 months
Overall Number of Participants Analyzed 32
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
sensory symptoms 17.3325  (0.9388)
motor symptoms 12.8499  (0.7835)
Time Frame While patients are active in trial: During 10 days of treatment and followed for 3 months after treatment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MC5A Calmare Therapy
Hide Arm/Group Description

Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.

electrical stimulation pain therapy : Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10

questionnaire administration : Brief Pain Inventory at baseline, weekly, then monthly for 3 months
All-Cause Mortality
MC5A Calmare Therapy
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
MC5A Calmare Therapy
Affected / at Risk (%) # Events
Total   1/39 (2.56%)    
Vascular disorders   
Thromboembolic event * 1 [1]  1/39 (2.56%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, NCI CTAE v4.0
[1]
Unrelated (Grade 2)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
MC5A Calmare Therapy
Affected / at Risk (%) # Events
Total   0/39 (0.00%)    
[Not Specified]
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: Dr. Craig W. Swainey
Organization: Virginia Commonwealth University
Phone: 804-828-9723
EMail: cswainey@mcvh-vcu.edu
Layout table for additonal information
Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01196442    
Other Study ID Numbers: MCC-13098
NCI-2010-01945 ( Registry Identifier: CTRP )
First Submitted: September 3, 2010
First Posted: September 8, 2010
Results First Submitted: October 11, 2012
Results First Posted: February 12, 2013
Last Update Posted: August 23, 2013