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

NCT ID: NCT02722434

Last Updated: 2022-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-13
• Study Completion Date: 2021-08-26

Brief Summary

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.

Detailed 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.

Conditions

Pain; Peripheral Neuropathy; Tingling

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Arm I (MC5-A scrambler therapy)

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

Group Type: EXPERIMENTAL

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

MC5-A Scrambler Therapy

Intervention Type: OTHER

Undergo Scrambler therapy

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Arm II (TENS therapy)

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

Group Type: ACTIVE_COMPARATOR

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Transcutaneous Electrical Nerve Stimulation

Intervention Type: OTHER

Undergo TENS

Interventions

Laboratory Biomarker Analysis

Correlative studies

Intervention Type: OTHER

MC5-A Scrambler Therapy

Undergo Scrambler therapy

Intervention Type: OTHER

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Transcutaneous Electrical Nerve Stimulation

Undergo TENS

Intervention Type: OTHER

Other Intervention Names

Scrambler Therapy; TENS; transcutaneous electric nerve stimulation

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles Loprinzi

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

References

Childs DS, Le-Rademacher JG, McMurray R, Bendel M, O'Neill C, Smith TJ, Loprinzi CL. Randomized Trial of Scrambler Therapy for Chemotherapy-Induced Peripheral Neuropathy: Crossover Analysis. J Pain Symptom Manage. 2021 Jun;61(6):1247-1253. doi: 10.1016/j.jpainsymman.2020.11.025. Epub 2020 Nov 27.

Reference Type: DERIVED

PMID: 33249081 (View on PubMed)

Cathcart-Rake EJ, Hilliker DR, Loprinzi CL. Chemotherapy-induced neuropathy: Central resolution of a peripherally perceived problem? Cancer. 2017 Jun 1;123(11):1898-1900. doi: 10.1002/cncr.30650. Epub 2017 Mar 3. No abstract available.

Reference Type: DERIVED

PMID: 28257145 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NCI-2016-00368

Identifier Type: REGISTRY

Identifier Source: secondary_id

MC15C1

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA015083

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MC15C1

Identifier Type: -

Identifier Source: org_study_id