Trial Outcomes & Findings for Electrical Stimulation Pain Therapy in Treating Chronic Pain and Numbness Caused By Chemotherapy in Patients With Cancer (NCT NCT01196442)

Results Overview

Change in Brief Pain Inventory (Now)Scale 1 (none) to 5 (complete interference)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

39 participants

Primary outcome timeframe

From day 1 to day 10

Results posted on

2013-08-23

Participant Flow

Subjects were enrolled from 08/30/2010 through 06/11/2012 at a medical clinical

No pre-assignment criteria

Participant milestones

Participant milestones
Measure	MC5A Calmare Therapy 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 Study STARTED	39
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MC5A Calmare Therapy n=39 Participants 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
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=93 Participants
Age, Categorical >=65 years	10 Participants n=93 Participants
Age Continuous	59 years STANDARD_DEVIATION 0.7 • n=93 Participants
Sex: Female, Male Female	23 Participants n=93 Participants
Sex: Female, Male Male	16 Participants n=93 Participants
Region of Enrollment United States	39 participants n=93 Participants

PRIMARY outcome

Timeframe: From day 1 to day 10

Change in Brief Pain Inventory (Now)Scale 1 (none) to 5 (complete interference)

Outcome measures

Outcome measures
Measure	Arm I n=39 Participants 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
Change in Pain Score From Day 1 to Day 10	-3.3 units on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: Day 1

Population: Participants at Day 1

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.

Outcome measures

Outcome measures
Measure	Arm I n=39 Participants 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
Effect of Electrical Stimulation Pain Therapy on Other Non-pain Symptoms at Day 1 sensory symptoms	20.4129 units on a scale Standard Error 0.9114
Effect of Electrical Stimulation Pain Therapy on Other Non-pain Symptoms at Day 1 motor symptoms	15.6268 units on a scale Standard Error 0.7598

SECONDARY outcome

Timeframe: From day 1 to day 30

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

Outcome measures

Outcome measures
Measure	Arm I n=39 Participants 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
Use of Medications Including Morphine Oral Dose Equivalents, Anti-depressants, and Neuroleptics	28.9 doses Standard Deviation 47.3

SECONDARY outcome

Timeframe: Day 10

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.

Outcome measures

Outcome measures
Measure	Arm I n=33 Participants 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
Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Day 10 sensory symptoms	17.8305 units on a scale Standard Error 0.9437
Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Day 10 motor symptoms	14.1815 units on a scale Standard Error 0.7878

SECONDARY outcome

Timeframe: month 1

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.

Outcome measures

Outcome measures
Measure	Arm I n=33 Participants 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
Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Month 1 snesory symptoms	16.5207 units on a scale Standard Error 0.9345
Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Month 1 motor symptoms	13.5443 units on a scale Standard Error 0.7797

SECONDARY outcome

Timeframe: month 2

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.

Outcome measures

Outcome measures
Measure	Arm I n=32 Participants 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
Effect of Electric Stimulation Pain Therapy n Other Non-pain Symptoms at Month 2 sensory symptoms	16.4723 units on a scale Standard Error 0.9480
Effect of Electric Stimulation Pain Therapy n Other Non-pain Symptoms at Month 2 motor symptoms	13.3816 units on a scale Standard Error 0.7917

SECONDARY outcome

Timeframe: Month 3

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.

Outcome measures

Outcome measures
Measure	Arm I n=32 Participants 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
Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Month 3 sensory symptoms	17.3325 units on a scale Standard Error 0.9388
Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Month 3 motor symptoms	12.8499 units on a scale Standard Error 0.7835

Adverse Events

MC5A Calmare Therapy

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MC5A Calmare Therapy n=39 participants at risk 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
Vascular disorders Thromboembolic event	2.6% 1/39 • Number of events 1 • While patients are active in trial: During 10 days of treatment and followed for 3 months after treatment.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Craig W. Swainey

Virginia Commonwealth University

Phone: 804-828-9723

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place