MC5-A Scrambler Therapy or TENS Therapy in Treating Patients With Chemotherapy-Induced Peripheral Neuropathy

Mayo Clinic

Status

Completed

Conditions

Tingling

Peripheral Neuropathy

Pain

Treatments

Other: Transcutaneous Electrical Nerve Stimulation

Other: Questionnaire Administration

Other: Laboratory Biomarker Analysis

Other: MC5-A Scrambler Therapy

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT02722434

P30CA015083 (U.S. NIH Grant/Contract)

MC15C1 (Other Identifier)

NCI-2016-00368 (Registry Identifier)

Details and patient eligibility

About

This randomized clinical trial studies how well MC5-A scrambler therapy or transcutaneous electrical nerve stimulation (TENS) therapy work in treating patients with chemotherapy-induced peripheral neuropathy (a nerve problem that causes pain, numbness, tingling, swelling, or muscle weakness in different parts of the body). MC5-A scrambler therapy is a type of treatment for nerve pain that uses electrodes placed on the skin, where electricity is carried from the electrodes through the skin and blocks the pain. TENS is a procedure in which mild electric currents are applied to some areas of the skin. It is not yet known whether TENS therapy is more effective than MC5-A scrambler therapy in treating chemotherapy-induced peripheral neuropathy.

Full description

PRIMARY OBJECTIVES:

I. Evaluate the efficacy of scrambler therapy (MC5-A scrambler therapy) compared to TENS therapy for pain and/or tingling related to chemotherapy-induced peripheral neuropathy (CIPN).

II. Evaluate the tolerability of scrambler therapy and compare it to TENS therapy, in this population.

III. Evaluate whether scrambler therapy, compared to TENS therapy, can decrease the use of pain medication for CIPN.

IV. Explore whether messenger ribonucleic acid (mRNA) gene expression before and after scrambler therapy shows similar findings to what Starkweather et al observed.

V. Utilizing high-field magnetic resonance imaging (MRI), to define alterations in functional differences (using resting state blood-oxygen-level dependent [BOLD] measures to measure differences in functional connectivity) in treated with the scrambler device in the setting of chemotherapy induced peripheral neuropathy pain.

VI. Explore whether scrambler therapy will alter sensation.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo MC5-A scrambler therapy over 30 minutes for 10 consecutive weekdays.

ARM II: Patients undergo TENS therapy over 30 minutes daily for 14 days.

Patients in both Arms, may crossover to the opposite Arm for an additional 2 weeks of treatment if they elect.

After completion of study treatment, patients are followed up weekly for 8 weeks.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Pain or symptoms of CIPN of >= 3 months duration, for which the patient wants intervention
- Note: neurotoxic chemotherapy must have been completed >= 3 months prior to registration and there must be no further planned neurotoxic chemotherapy for > 5 months after registration
Patients have to relate that tingling or pain was at least a four out of ten problem =< 7 days prior to registration, on a 0-10 scale where zero was no problem and ten was the worst possible problem
- Note: the patient is expected to have tingling or pain of at least 4/10 at the time of the first treatment
Eastern Cooperative Oncology Group (ECOG) performance status (PS) = 0, 1, or 2
Life expectancy >= 6 months
Ability to complete questionnaire(s) by themselves or with assistance
Ability to provide informed written consent
Case review by the study chair, or designate, as a case where treatment should be tried

Exclusion criteria

Any of the following:
- Pregnant women
- Nursing women
- Women of childbearing potential who are unwilling to employ adequate contraception
Existing operational implantable drug delivery systems, e.g. Medtronic Synchromed
Existing implantable medical electronic devices, life-supporting medical devices, and medical monitoring devices
- Note: metal implants for orthopedic repair, e.g. pins, clips, plates, cages, joint replacements are allowed as are central venous access devices
History of myocardial infarction or ischemic heart disease within the past six months
History of epilepsy, brain damage, use of anticonvulsants for seizure prevention, concurrently using ketamine, symptomatic brain metastases
Skin conditions such as open sores that would prevent proper application of the electrodes
Other medical or other condition(s) that in the opinion of the investigators might compromise the objectives of the study
Currently receiving gabapentin or pregabalin and not willing to be weaned off of these medications prior to Scrambler therapy initiation
- Note: it is OK to continue these medications in patients who are receiving TENS
History of peripheral neuropathy prior to receiving neurotoxic chemotherapy
Prior treatment with Scrambler therapy