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

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ClinicalTrials.gov Identifier: NCT02722434
Recruitment Status : Active, not recruiting
First Posted : March 30, 2016
Last Update Posted : September 18, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Pain Peripheral Neuropathy Tingling Other: Laboratory Biomarker Analysis Other: MC5-A Scrambler Therapy Other: Questionnaire Administration Other: Transcutaneous Electrical Nerve Stimulation Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: MC15C1 Randomized Scrambler Therapy vs TENS for the Treatment of Chemotherapy-Induced Peripheral Neuropathy
Actual Study Start Date : April 2016
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm I (MC5-A scrambler therapy)
Patients undergo MC5-A scrambler therapy over 30 minutes for 10 consecutive weekdays.
Other: Laboratory Biomarker Analysis
Correlative studies

Other: MC5-A Scrambler Therapy
Undergo Scrambler therapy
Other Name: Scrambler Therapy

Other: Questionnaire Administration
Ancillary studies

Active Comparator: Arm II (TENS therapy)
Patients undergo TENS therapy over 30 minutes daily for 14 days.
Other: Laboratory Biomarker Analysis
Correlative studies

Other: Questionnaire Administration
Ancillary studies

Other: Transcutaneous Electrical Nerve Stimulation
Undergo TENS
Other Names:
  • TENS
  • transcutaneous electric nerve stimulation




Primary Outcome Measures :
  1. Changes in proportion of patients who achieve at least 50% reduction in pain or tingling [ Time Frame: Baseline to up to 8 weeks ]
    Descriptive statistics (mean, standard deviation [sd], median, range) of pain and tingling scores and changes pre- and post-treatment scores will be summarized and the percentage of pain and tingling reduction from baseline will be calculated for each time point, separately by treatment arm. Longitudinal plots of scores by arm will be provided. The frequency and percentages of patients who achieved more than 50% reduction in pain and/or tingling scores after 2 weeks of therapy and after 8 weeks of observation from baseline will be summarized by treatment arm and will be compared between arms u


Secondary Outcome Measures :
  1. Change in functional MRI (fMRI) [ Time Frame: Baseline to up to 8 weeks ]
    Changes in fMRI following Scrambler therapy will be described in the subset of patients selected for this component of the study.

  2. Change in mRNA gene expression [ Time Frame: Baseline to up to 8 weeks ]
    In a descriptive manner, the gene expression will be compared to what was previously reported by Starkweather et al.

  3. Change in sensation [ Time Frame: Baseline to up to 8 weeks ]
    Descriptive statistics will be used for the data from Quantitative Sensory Testing.

  4. Change in use of pain medication for CIPN [ Time Frame: Baseline to up to 8 weeks ]
    Type and frequency of analgesic used will be summarized by treatment arms and will be compared using Fisher-exact test.

  5. Incidence of toxicity [ Time Frame: Up to 8 weeks ]
    Frequency and type of toxicities occurred during therapy will be summarized by treatment arm and compared between arms using Fisher-exact test.

  6. Perceived treatment efficacy using Subjective Global Impression of Change instrument [ Time Frame: Up to 8 weeks ]
    Will be summarized using median and range for impression of change and frequency for preference, by arm, and compared using Wilcoxon rank-sum test for impression of change and Chi-square test for preference, between treatment arms. European Organization for Research and Treatment of Cancer CIPN20 scores and changes in scores will be summarized (mean, sd, median, range) at each time point by arm and will be compared between arms using two-sample t-tests.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02722434


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
Principal Investigator: Charles Loprinzi Mayo Clinic

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT02722434     History of Changes
Other Study ID Numbers: MC15C1
NCI-2016-00368 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
MC15C1 ( Other Identifier: Mayo Clinic )
P30CA015083 ( U.S. NIH Grant/Contract )
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases