Chemotherapeutic Agent Toxicity, Neurotoxicity, Pain, Peripheral Neuropathy, Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
pain, neurotoxicity, chemotherapeutic agent toxicity, unspecified adult solid tumor, protocol specific, peripheral neuropathy
Brief summary
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.
Detailed description
OBJECTIVES: Primary * To determine if MC5-A Scrambler therapy will improve the pain associated with chemotherapy-induced peripheral neuropathy in cancer patients by 20%. Secondary * To evaluate the effect of MC5-A therapy on specific pain and neuropathy scales. * To evaluate the effect of MC5-A therapy on overall quality of life. * To evaluate the effect of MC5-A therapy on other pain drugs used. * To evaluate the toxicities of MC5-A therapy. 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.
Interventions
OTHERquestionnaire administration
Pain Rating Score
OTHERSensory Neuropathy Scale instrument
ECOG Common Toxicity Criteria for Sensory Neuropathy scale
OTHERQuality of Life instrument
Uniscale 0-100 scale global quality of life
DEVICEMC5-A Scrambler device
Electrical stimulation for 60 minutes
Sponsors
National Cancer Institute (NCI)
Virginia Commonwealth University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Chemotherapy-induced peripheral neuropathy (CIPN) meeting the following criteria: * More than 4 weeks since prior neurotoxic chemotherapy including taxanes (e.g., paclitaxel or docetaxel), platinum-based compounds (e.g., carboplatin, cis-platinum, oxaliplatin), vinca-alkaloids (e.g., vincristine, vinblastine, or vinorelbine), or proteosome inhibitors (e.g., bortezomib) * Pain or symptoms of peripheral neuropathy for ≥ 1 month attributed to CIPN * Pain stable for ≥ 2 weeks * Average daily pain rating of ≥ 5 out of 10 using the pain numerical rating scale (0 is no pain and 10 is worst pain possible) * No symptomatic brain metastases PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy ≥ 3 months * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No history of an allergic reaction or intolerance to transcutaneous electronic nerve stimulation * No pacemaker or implantable drug-delivery system (e.g., Medtronic Synchromed) * No heart stent or vena cava clips * No history of epilepsy or brain damage * No other identified causes of painful paresthesias existing before chemotherapy (e.g., radiation or malignant plexopathy, lumbar or cervical radiculopathy, pre-existing peripheral neuropathy of another etiology \[e.g., B12 deficiency, AIDS, monoclonal gammopathy, diabetes, heavy metal poisoning amyloidosis, syphilis, hyperthyroidism, hypothyroidism, inherited neuropathy, etc.\]) * No skin conditions (e.g., open sores) that would prevent proper application of the electrodes * No other medical or other conditions that, in the opinion of the investigators, might compromise the objectives of the study 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: * Pain is not satisfactorily controlled * Dose of the other medication has been stable for ≥ 4 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Score | 15 days | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of MC5-A on Pain and Neuropathy | 2 weeks | 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. |
| Effect of MC5-A on Morphine Oral Equivalent Doses Used Before and After MC5-A Therapy | 2 weeks | 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 |
| Toxicity of MC5-A Therapy on Global Quality of Life Using the Uniscale Instrument | 2 weeks | 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. |
Participant flow
Recruitment details
Dates of recruitment: 06/12/2009 - 10/26/2009 Location of recruitment: medical clinic
Participants by arm
| Arm | Count |
|---|---|
| MC5-A Scrambler Instrument Treatment of chronic neuropathic pain with the MC5-A device | 18 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | MC5-A Scrambler Instrument |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants |
| Age, Continuous | 60 years STANDARD_DEVIATION 5 |
| Region of Enrollment United States | 18 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 18 |
| serious Total, serious adverse events | 1 / 18 |
Outcome results
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)
Time frame: 15 days
Population: Patients treated with MC5A devise for 10 consectuvive days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MC5-A Pain Treatment Device | Change in Pain Score | 2.4 units on a scale |
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
Time frame: 2 weeks
Population: Patients treated with MC5A devise for 10 consectuvive days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MC5-A Pain Treatment Device | Effect of MC5-A on Morphine Oral Equivalent Doses Used Before and After MC5-A Therapy | -41.25 mg/24hr |
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.
Time frame: 2 weeks
Population: Patients treated with MC5A devise for 10 consectuvive days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MC5-A Pain Treatment Device | Effect of MC5-A on Pain and Neuropathy | 1.3 units on a scale |
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.
Time frame: 2 weeks
Population: Patients treated with MC5A devise for 10 consectuvive days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MC5-A Pain Treatment Device | Toxicity of MC5-A Therapy on Global Quality of Life Using the Uniscale Instrument | 0.08 units on a scale |