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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
39
Electrical stimulation pain therapy for 45 minutes on Day 1, then 30 minutes Days 2-10
Brief Pain Inventory questionnaire administration at baseline, weekly, then monthly for 3 months
Virginia Commonwealth University
Richmond, Virginia, United States
Change in Pain Score From Day 1 to Day 10
Change in Brief Pain Inventory (Now)Scale 1 (none) to 5 (complete interference)
Time frame: From day 1 to day 10
Effect of Electrical Stimulation Pain Therapy on Other Non-pain Symptoms 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.
Time frame: Day 1
Use of Medications Including Morphine Oral Dose Equivalents, Anti-depressants, and Neuroleptics
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
Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at 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.
Time frame: Day 10
Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at 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.
Time frame: month 1
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Effect of Electric Stimulation Pain Therapy n Other Non-pain Symptoms at 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.
Time frame: month 2
Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at 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.
Time frame: Month 3