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

NCT02722434 | Completed Results DMC

• 3 other identifiers: MC15C1NCI-2016-00368P30CA015083
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Peripheral Neuropathy; Tingling

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Achieve at Least a 50% Reduction in Their Primary Problematic Symptom (Either Pain or Tingling) From Baseline on Day 14

  The number of participants who achieve at least a 50% reduction in their primary problematic symptom (either pain or tingling) from baseline on Day 14. The participant specified their primary problematic symptom (either pain or tingling) and primary problematic area (either upper or lower extremity) at registration; the respective items used to measure each symptom are considered for this outcome measure. Pain and tingling are measured using either item #6 (How much tingling have you had in your \[fingers or hands; toes or feet\] on average over the past 24 hours?) or item #9 (How much pain have you had in your \[fingers or hands; toes or feet\] on average over the past 24 hours?). Both items use the same scale: 0=None, 10=As bad as can be, with higher scores indicating worse outcome on either the Patient Questionnaire: Before Each Treatment for Upper Extremity Neuropathy or Patient Questionnaire: Before Each Treatment for Lower Extremity Neuropathy at baseline and Day 14.

  Baseline to Day 14

Secondary Outcomes (3)

• 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

  At 10 weeks

• Change in Sensory, Motor, and Autonomic Neuropathy Subscale Scores From Baseline to Week 10

  Up to 10 weeks

• Number of Participants Using Acetaminophen as Pain Medication

  Up to 10 weeks

Other Outcomes (3)

• Change in mRNA Gene Expression

  Baseline to up to 10 weeks

• Change in Functional MRI (fMRI)

  Baseline to up to 10 weeks

• Change in Sensation

  Baseline to up to 10 weeks

Study Arms (2)

Arm I (MC5-A scrambler therapy)

EXPERIMENTAL

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

Other: Laboratory Biomarker Analysis; Other: MC5-A Scrambler Therapy; Other: Questionnaire Administration

Arm II (TENS therapy)

ACTIVE COMPARATOR

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

Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration; Other: Transcutaneous Electrical Nerve Stimulation

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm I (MC5-A scrambler therapy); Arm II (TENS therapy)

MC5-A Scrambler Therapy OTHER

Undergo Scrambler therapy

Also known as: Scrambler Therapy

Arm I (MC5-A scrambler therapy)

Questionnaire Administration OTHER

Ancillary studies

Arm I (MC5-A scrambler therapy); Arm II (TENS therapy)

Transcutaneous Electrical Nerve Stimulation OTHER

Undergo TENS

Also known as: TENS, transcutaneous electric nerve stimulation

Arm II (TENS therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (2)

• 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.

  PMID: 33249081 DERIVED

• 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.

  PMID: 28257145 DERIVED

MeSH Terms

Conditions

Pain; Peripheral Nervous System Diseases; Paresthesia

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neuromuscular Diseases; Nervous System Diseases; Somatosensory Disorders; Sensation Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Results Point of Contact

• Title: Charles L Loprinzi MD
• Organization: Mayo Clinic

cloprinzi@mayo.edu

507/284-2511

Study Officials

• Charles Loprinzi

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2016
• First Posted: March 30, 2016
• Study Start: April 13, 2016
• Primary Completion: September 1, 2017
• Study Completion: August 26, 2021
• Last Updated: January 12, 2022
• Results First Posted: January 12, 2022

Record last verified: 2021-06

Locations

US (1)