Electrical Stimulation Therapy Using the MC5-A Scrambler in Reducing Peripheral Neuropathy Caused by Chemotherapy

Virginia Commonwealth University (VCU)

Status and phase

Completed

Phase 2

Conditions

Chemotherapeutic Agent Toxicity

Peripheral Neuropathy

Unspecified Adult Solid Tumor, Protocol Specific

Pain

Neurotoxicity

Treatments

Other: Quality of Life instrument

Device: MC5-A Scrambler device

Other: Sensory Neuropathy Scale instrument

Other: questionnaire administration

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00952848

MCV-MCC-12110 (Other Identifier)

CDR0000644516

Details and patient eligibility

About

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.

Full 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.

Enrollment

18 patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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