Clinical trial NCT02722434: MC5-A Scrambler Therapy or TENS Therapy in Treating Patients With Chemotherapy-Induced Peripheral Neuropathy
Official title: MC15C1 Randomized Scrambler Therapy vs TENS for the Treatment of Chemotherapy-Induced Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Peripheral Neuropathy
Tingling
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-03-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Number of Participants Who Achieve at Least a 50% Reduction in Their Primary Problematic Symptom (Either Pain or Tingling) From Baseline on Day 14
timeFrame: Baseline to Day 14
Secondary outcomes:
measure: Number of Participants Indicating Yes, No, or Unsure for Therapy Recommendation to Other Patients With Similar Problems on the Subjective Global Impression of Change Instrument
timeFrame: At 10 weeks
measure: Change in Sensory, Motor, and Autonomic Neuropathy Subscale Scores From Baseline to Week 10
timeFrame: Up to 10 weeks
measure: Number of Participants Using Acetaminophen as Pain Medication
timeFrame: Up to 10 weeks
Other outcomes:
measure: Change in mRNA Gene Expression
timeFrame: Baseline to up to 10 weeks
measure: Change in Functional MRI (fMRI)
timeFrame: Baseline to up to 10 weeks
measure: Change in Sensation
timeFrame: Baseline to up to 10 weeks
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Charles Loprinzi
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.