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| ID | Type | Description | Link |
|---|---|---|---|
| MCV-MCC-12110 | Other Identifier | VCU Massey Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Electronic stimulation using a MC5-A Scrambler may help relieve pain in patients who develop peripheral neuropathy while undergoing chemotherapy treatments for cancer.
PURPOSE: This phase II trial is studying how well MC5-A Scrambler therapy works in reducing peripheral neuropathy caused by chemotherapy.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients undergo gel electrode application on the skin in the most pain-free of the pain-affected area. Patients undergo treatment with the MC5-A Scrambler machine over 60 minutes once daily on days 1-10. On day 1, the treatment intensity is increased every 10 minutes to the maximum intensity individually bearable by the patient without any input of pain or discomfort. The patient should feel the disappearance of the pain during treatment as a sign that the proper nerve pathway(s) has (have) been correctly identified. Subsequent treatments begin at the highest intensity tolerated at the previous treatment. Patients with no improvement after 3 treatments discontinue treatment.
Patients complete questionnaires about symptoms, pain, and quality of life periodically.
After completion of study treatment, patients are followed up at 2 and 4 weeks, monthly for 3 months, and at 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MC5-A Scramble instrument | Experimental | Treatment of chronic neuropathic pain with the MC5-A device |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| questionnaire administration | Other | Pain Rating Score |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Score | Change in Neumeric Rating Score for Pain as measured by a Numeric Pain Rating scale between day 0 to day 15. Scale is 0 (none) to 10 (severe) | 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of MC5-A on Pain and Neuropathy | Change on pain and neuropathy as measured by the Eastern Cooperative Oncology Group (ECOG) Common Toxicity Criteria for Sensory Neuropathy scale,0=none to 4=paralysis; the World Health Organization (WHO) Classification Scale, 0=none to 4=paralysis; and the Brief Pain Inventory-Short Form, 0=none to 4=most intense pain imaginable. Scores will be averaged. | 2 weeks |
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DISEASE CHARACTERISTICS:
Chemotherapy-induced peripheral neuropathy (CIPN) meeting the following criteria:
No symptomatic brain metastases
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
At least 30 days since prior and no concurrent investigational agents for pain control
More than 4 weeks since prior and no concurrent celiac plexus block or other neurolytic pain control treatment
No prior or concurrent anti-convulsants
No concurrent neurotoxic or potentially neurotoxic chemotherapy
Concurrent pain treatments allowed provided the following criteria are met:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas J. Smith, MD | Massey Cancer Center | Principal Investigator |
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Dates of recruitment: 06/12/2009 - 10/26/2009 Location of recruitment: medical clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | MC5-A Scrambler Instrument | Treatment of chronic neuropathic pain with the MC5-A device |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Sensory Neuropathy Scale instrument |
| Other |
ECOG Common Toxicity Criteria for Sensory Neuropathy scale |
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| Quality of Life instrument | Other | Uniscale 0-100 scale global quality of life |
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| MC5-A Scrambler device | Device | Electrical stimulation for 60 minutes |
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| Effect of MC5-A on Morphine Oral Equivalent Doses Used Before and After MC5-A Therapy | The change in overal equivalent doses (all narcotic doses will be converted to morphine oral equivalent doses ie as mg/24hours. (All opiates taken will be recorded for the full 24 hours preceding the visit or phone call. All opiates will be converted to the pnmorphine equivalent using the Morphine oral dose equivalents (MOED). The total MOEDs taken during the 24 hours will be the sum of all opiates taken) used before intervention | 2 weeks |
| Toxicity of MC5-A Therapy on Global Quality of Life Using the Uniscale Instrument | Change on global quality of life. The global quality of life will improve as measured by the Uniscale Linear Analog Scale Assessment (LASA) quality of life scale 0=as bad as it can be to 10=as good as it can be. Scores will be averaged. | 2 weeks |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | MC5-A Scrambler Instrument | Treatment of chronic neuropathic pain with the MC5-A device |
| 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 | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Change in Neumeric Rating Score for Pain as measured by a Numeric Pain Rating scale between day 0 to day 15. Scale is 0 (none) to 10 (severe) | Patients treated with MC5A devise for 10 consectuvive days | Posted | Median | 90% Confidence Interval | units on a scale | 15 days |
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| Secondary | Effect of MC5-A on Pain and Neuropathy | Change on pain and neuropathy as measured by the Eastern Cooperative Oncology Group (ECOG) Common Toxicity Criteria for Sensory Neuropathy scale,0=none to 4=paralysis; the World Health Organization (WHO) Classification Scale, 0=none to 4=paralysis; and the Brief Pain Inventory-Short Form, 0=none to 4=most intense pain imaginable. Scores will be averaged. | Patients treated with MC5A devise for 10 consectuvive days | Posted | Median | 90% Confidence Interval | units on a scale | 2 weeks |
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| Secondary | Effect of MC5-A on Morphine Oral Equivalent Doses Used Before and After MC5-A Therapy | The change in overal equivalent doses (all narcotic doses will be converted to morphine oral equivalent doses ie as mg/24hours. (All opiates taken will be recorded for the full 24 hours preceding the visit or phone call. All opiates will be converted to the pnmorphine equivalent using the Morphine oral dose equivalents (MOED). The total MOEDs taken during the 24 hours will be the sum of all opiates taken) used before intervention | Patients treated with MC5A devise for 10 consectuvive days | Posted | Median | 90% Confidence Interval | mg/24hr | 2 weeks |
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| Secondary | Toxicity of MC5-A Therapy on Global Quality of Life Using the Uniscale Instrument | Change on global quality of life. The global quality of life will improve as measured by the Uniscale Linear Analog Scale Assessment (LASA) quality of life scale 0=as bad as it can be to 10=as good as it can be. Scores will be averaged. | Patients treated with MC5A devise for 10 consectuvive days | Posted | Median | 90% Confidence Interval | units on a scale | 2 weeks |
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6 months
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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 | MC5-A Scrambler Instrument | Treatment of chronic neuropathic pain with the MC5-A device | 1 | 18 | 0 | 18 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Seizure | Nervous system disorders | NCI CTCAE v3.0 | Non-systematic Assessment | Unrelated to intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas J. Smith, MD, FACP | Virginia Commonwealth University | 410-955-2091 | tsmit136@jhmi.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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