N/A
N=50
MC5-A Scrambler Therapy or TENS Therapy in Treating Patients With Chemotherapy-Induced Peripheral Neuropathy
Pain · Peripheral Neuropathy · Tingling
Bottom Line
View on ClinicalTrials.gov: NCT02722434 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcome: Primary: Number of Participants Who Achieve at Least a 50% Reduction in Their Primary Problematic Symptom (Either Pain or Tingling) From Baseline on Day 14 — 10; 5 Participants — p=0.1228
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Laboratory Biomarker Analysis (Other); MC5-A Scrambler Therapy (Other); Questionnaire Administration (Other); Transcutaneous Electrical Nerve Stimulation (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Achieve at Least a 50% Reduction in Their Primary Problematic Symptom (Either Pain or Tingling) From Baseline on Day 14 |
10; 5 | 0.1228 |
| SECONDARY 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 |
16; 7; 0; 7; 5; 3 | 0.004 sig |
| SECONDARY Change in Sensory, Motor, and Autonomic Neuropathy Subscale Scores From Baseline to Week 10 |
-0.4; -0.6; -0.1; -0.3; 0.0; 0.0 | 0.79 |
| SECONDARY Number of Participants Using Acetaminophen as Pain Medication |
8; 9 | — |
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.
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 = = 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
Data sourced from ClinicalTrials.gov (NCT02722434). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.