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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: An Expanded Trial of MC5-A Calmare Therapy in the Treatment of Cancer Pain Syndromes and Chronic Chemotherapy-Induced Peripheral Neuropathy Including Pain and Numbness

Brief Summary: RATIONALE: Electrical stimulation pain therapy may help relieve chronic pain and numbness caused by chemotherapy. PURPOSE: This pilot trial studies electrical stimulation pain therapy in treating chronic pain and numbness caused by chemotherapy in patients with cancer.

Detailed Summary:

OBJECTIVES:

I. To evaluate the effect of MC5-A on pain symptoms both immediately and over time.

II. To evaluate the effect of Calmare therapy on other non-pain symptoms. III. To evaluate the effect of MC5-A on daily opioid and other pain medication use.

OUTLINE: Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days. After completion of study treatment, patients are followed up for 3 months.


Sponsor: Virginia Commonwealth University

Current Primary Outcome: Change in Pain Score From Day 1 to Day 10 [ Time Frame: From day 1 to day 10 ]

Change in Brief Pain Inventory (Now)Scale

1 (none) to 5 (complete interference)



Original Primary Outcome: Change in Pain Score for Pain Immediately and Over Time [ Time Frame: From day 1 to day 10 ]

Current Secondary Outcome:

  • Effect of Electrical Stimulation Pain Therapy on Other Non-pain Symptoms at Day 1 [ Time Frame: 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.
  • Use of Medications Including Morphine Oral Dose Equivalents, Anti-depressants, and Neuroleptics [ Time Frame: 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
  • Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Day 10 [ Time Frame: 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.
  • Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Month 1 [ Time Frame: 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.
  • Effect of Electric Stimulation Pain Therapy n Other Non-pain Symptoms at Month 2 [ Time Frame: 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.
  • Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Month 3 [ Time Frame: 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.


Original Secondary Outcome:

  • Effect of Electrical Stimulation Pain Therapy on Other Non-pain Symptoms [ Time Frame: At days 1 and 10 and months 1, 2 and 3 ]
  • Use of Medications Including Morphine Oral Dose Equivalents, Anti-depressants, and Neuroleptics [ Time Frame: From day 1 to day 10 ]


Information By: Virginia Commonwealth University

Dates:
Date Received: September 3, 2010
Date Started: September 2010
Date Completion:
Last Updated: August 21, 2013
Last Verified: August 2013