A Study Comparing Scrambler Therapy versus TENS Therapy in Treating Patients with Chemotherapy-Induced Peripheral Neuropathy

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 15-008089
    NCT ID: NCT02722434
    Sponsor Protocol Number: MC15C1

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Charles Loprinzi, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

.
CLS-20199631

Mayo Clinic Footer