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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2010-01945 | Registry Identifier | CTRP |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I electric stimulation pain therapy | Experimental | Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| electrical stimulation pain therapy | Other | Electrical stimulation pain therapy for 45 minutes on Day 1, then 30 minutes Days 2-10 |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Score From Day 1 to Day 10 | Change in Brief Pain Inventory (Now)Scale 1 (none) to 5 (complete interference) | From day 1 to day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Craig Swainey, MD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
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| Label | URL |
|---|---|
| VCU Massey Cancer Center | View source |
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No pre-assignment criteria
Subjects were enrolled from 08/30/2010 through 06/11/2012 at a medical clinical
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| questionnaire administration | Other | Brief Pain Inventory questionnaire administration at baseline, weekly, then monthly for 3 months |
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| 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 | 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. | 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. | month 1 |
| 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. | 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. | Month 3 |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Pain Score From Day 1 to Day 10 | Change in Brief Pain Inventory (Now)Scale 1 (none) to 5 (complete interference) | Posted | Mean | Standard Deviation | units on a scale | From day 1 to day 10 |
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| Secondary | 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. | Participants at Day 1 | Posted | Least Squares Mean | Standard Error | units on a scale | Day 1 |
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| Secondary | 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 | Posted | Mean | Standard Deviation | doses | From day 1 to day 30 |
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| Secondary | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Day 10 |
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| Secondary | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | month 1 |
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| Secondary | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | month 2 |
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| Secondary | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Month 3 |
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While patients are active in trial: During 10 days of treatment and followed for 3 months after treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 1 | 39 | 0 | 39 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thromboembolic event | Vascular disorders | NCI CTAE v4.0 | Non-systematic Assessment | Unrelated (Grade 2) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Craig W. Swainey | Virginia Commonwealth University | 804-828-9723 | cswainey@mcvh-vcu.edu |
| ID | Term |
|---|---|
| D020258 | Neurotoxicity Syndromes |
| D010146 | Pain |
| D010523 | Peripheral Nervous System Diseases |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D000698 | Analgesia |
| D059408 | Pain Management |
| ID | Term |
|---|---|
| D000760 | Anesthesia and Analgesia |
| D013812 | Therapeutics |
| D019468 | Disease Management |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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