An interventional study of Laboratory Biomarker Analysis and MC5-A Scrambler Therapy in Pain, Peripheral Neuropathy and Tingling, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-12.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Supportive care
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.
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.
1,003 studies on the registry are indexed under Peripheral Nervous System Diseases; 177 are open to participants now.
This study's enrollment of 50 is below the median of 60 across 768 interventional studies indexed under Peripheral Nervous System Diseases.
Browse Peripheral Nervous System Diseases studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Pain or symptoms of CIPN of >= 3 months duration, for which the patient wants intervention
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
Exclusion Criteria:
Any of the following:
Existing implantable medical electronic devices, life-supporting medical devices, and medical monitoring devices
Currently receiving gabapentin or pregabalin and not willing to be weaned off of these medications prior to Scrambler therapy initiation
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
Patients undergo TENS therapy over 30 minutes daily for 14 days.
Other: Laboratory Biomarker Analysis · Other: Questionnaire Administration · Other: Transcutaneous Electrical Nerve Stimulation
Correlative studies
Undergo Scrambler therapy
Also known as: Scrambler Therapy
Ancillary studies
Undergo TENS
Also known as: TENS, transcutaneous electric nerve stimulation
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.
Time frame: Baseline to Day 14
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
The number of participants indicating 'Yes' for 'Therapy recommendation to other patients with similar problems' on the Subjective Global Impression of Change (SGIC) instrument. The SGIC questionnaire is used to assess the change in quality of life.
Time frame: At 10 weeks
Change in Sensory, Motor, and Autonomic Neuropathy Subscale Scores From Baseline to Week 10
The change in Sensory, Motor, and Autonomic Neuropathy Subscale Scores from Baseline to Week 10 will be derived by subtracting the baseline score from the scores at Week 10. The European Organisation for Research and Treatment of Cancer Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ CIPN-20) Instrument contains 20 items assessing sensory (9 items), motor (8 items), and autonomic symptoms (3 items), using a 4-point Likert scale (1 = "not at all," 2 = "a little," 3 = "quite a bit," and 4 = "very much"). The range of change in subscale scores is -3 to 3. With a total range for sensory being -27 to 27 and motor being -24 to 24 and autonomic being -9 to 9. With negatives meaning a decrease in neuropathy and positive being an increase.
Time frame: Up to 10 weeks
Number of Participants Using Acetaminophen as Pain Medication
The number of participants using acetaminophen as pain medication is reported below.
Time frame: Up to 10 weeks
Change in mRNA Gene Expression
In a descriptive manner, the gene expression will be compared to what was previously reported by Starkweather et al.
Time frame: Baseline to up to 10 weeks
Change in Functional MRI (fMRI)
Changes in fMRI following Scrambler therapy will be described in the subset of patients selected for this component of the study.
Time frame: Baseline to up to 10 weeks
Change in Sensation
Descriptive statistics will be used for the data from Quantitative Sensory Testing.
Time frame: Baseline to up to 10 weeks
| Milestone | Arm I (MC5-A Scrambler Therapy) | Arm II (TENS Therapy) |
|---|---|---|
| Started | 25 | 25 |
| Started treatment | 24 | 25 |
| Completed | 24 | 22 |
| Not completed | 1 | 3 |
| Withdrew: Withdrawal prior to beginning treatment | 1 | 0 |
| Withdrew: Withdrawal after beginning treatment | 0 | 3 |
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.
| Participants | Arm I (MC5-A Scrambler Therapy) | Arm II (TENS Therapy) |
|---|---|---|
| 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 |
The number of participants indicating 'Yes' for 'Therapy recommendation to other patients with similar problems' on the Subjective Global Impression of Change (SGIC) instrument. The SGIC questionnaire is used to assess the change in quality of life.
| Participants | Arm I (MC5-A Scrambler Therapy) | Arm II (TENS Therapy) |
|---|---|---|
| Yes | 16 | 7 |
| No | 0 | 7 |
| Unsure | 5 | 3 |
The change in Sensory, Motor, and Autonomic Neuropathy Subscale Scores from Baseline to Week 10 will be derived by subtracting the baseline score from the scores at Week 10. The European Organisation for Research and Treatment of Cancer Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ CIPN-20) Instrument contains 20 items assessing sensory (9 items), motor (8 items), and autonomic symptoms (3 items), using a 4-point Likert scale (1 = "not at all," 2 = "a little," 3 = "quite a bit," and 4 = "very much"). The range of change in subscale scores is -3 to 3. With a total range for sensory being -27 to 27 and motor being -24 to 24 and autonomic being -9 to 9. With negatives meaning a decrease in neuropathy and positive being an increase.
| score on a scale | Arm I (MC5-A Scrambler Therapy) | Arm II (TENS Therapy) |
|---|---|---|
| Sensory Subscale | -0.4 (-2.4 to 0.1) | -0.6 (-1.4 to 0.3) |
| Motor Subscale | -0.1 (-1.5 to 0.5) | -0.3 (-1.7 to 0.3) |
| Autonomic Subscale | 0.0 (-1.0 to 0.3) | 0.0 (-1.0 to 0.5) |
The number of participants using acetaminophen as pain medication is reported below.
| Participants | Arm I (MC5-A Scrambler Therapy) | Arm II (TENS Therapy) |
|---|---|---|
| Number of Participants Using Acetaminophen as Pain Medication | 8 | 9 |
In a descriptive manner, the gene expression will be compared to what was previously reported by Starkweather et al.
Results for this outcome have not been posted.
Changes in fMRI following Scrambler therapy will be described in the subset of patients selected for this component of the study.
Results for this outcome have not been posted.
Descriptive statistics will be used for the data from Quantitative Sensory Testing.
Results for this outcome have not been posted.
Collected over Up to 10 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm I (MC5-A Scrambler Therapy) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) |
| Arm II (TENS Therapy) | 0/25 (0%) | 0/25 (0%) | 1/25 (4%) |
| Event | Arm I (MC5-A Scrambler Therapy) | Arm II (TENS Therapy) |
|---|---|---|
| FractureInjury, poisoning and procedural complications | 0/24 | 1/25 |
All Participants
| Age, Continuous(years) | Arm I (MC5-A Scrambler Therapy) | Arm II (TENS Therapy) | Total |
|---|---|---|---|
| Median | 61.0 (30.0 to 82.0) | 61.0 (52.0 to 77.0) | 61.0 (30.0 to 82.0) |
| Sex: Female, Male(Participants) | Arm I (MC5-A Scrambler Therapy) | Arm II (TENS Therapy) | Total |
|---|---|---|---|
| Female | 17 | 17 | 34 |
| Male | 8 | 8 | 16 |
| Race (NIH/OMB)(Participants) | Arm I (MC5-A Scrambler Therapy) | Arm II (TENS Therapy) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 0 | 3 |
| White | 21 | 24 | 45 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 1 |
| ECOG Performance Status(Participants) | Arm I (MC5-A Scrambler Therapy) | Arm II (TENS Therapy) | Total |
|---|---|---|---|
| 0 | 15 | 14 | 29 |
| 1 | 9 | 10 | 19 |
| 2 | 1 | 1 | 2 |
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