PainNCT02722434
MC5-A Scrambler Therapy or TENS Therapy in Treating Patients With Chemotherapy-Induced Peripheral Neuropathy
A study testing Laboratory Biomarker Analysis, MC5-A Scrambler Therapy and Questionnaire Administration in people with Pain and Peripheral Neuropathy, run by Mayo Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Peripheral Neuropathy, Tingling
- What is being tested?
- Laboratory Biomarker Analysis, MC5-A Scrambler Therapy and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2016to 26 Aug 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MC15C1 Randomized Scrambler Therapy vs TENS for the Treatment of Chemotherapy-Induced Peripheral Neuropathy
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- 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.
- Conditions
- Pain, Peripheral Neuropathy, Tingling
- Being tested
- Laboratory Biomarker Analysis, MC5-A Scrambler Therapy, Questionnaire Administration, Transcutaneous Electrical Nerve Stimulation
- Medical subject headings
- Pain, Peripheral Nervous System Diseases, Paresthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory Biomarker AnalysisOther
Correlative studies
MC5-A Scrambler TherapyOther
Also called Scrambler Therapy
Undergo Scrambler therapy
Questionnaire AdministrationOther
Ancillary studies
Transcutaneous Electrical Nerve StimulationOther
Also called TENS, transcutaneous electric nerve stimulation
Undergo TENS
| Study group | Role | What they receive |
|---|---|---|
| Arm I (MC5-A scrambler therapy) | Experimental | Patients undergo MC5-A scrambler therapy over 30 minutes for 10 consecutive weekdays. Receives: 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. Receives: Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration; Other: Transcutaneous Electrical Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: Up to 10 weeks
Number of Participants Using Acetaminophen as Pain Medication
The number of participants using acetaminophen as pain medication is reported below.
Measured: Up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2016 (estimated)
- Study start13 Apr 2016
- Primary completion1 Sep 2017
- Study completion26 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Charles Loprinzi, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02722434
- Sponsor's protocol ID
- MC15C1
- Other IDs
- NCI-2016-00368, MC15C1, P30CA015083
- Status last verified
- Jun 2021
- First submitted
- 23 Mar 2016
- Last updated
- 12 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 33249081Cathcart-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.
PubMed 28257145
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MC15C1 Randomized Scrambler Therapy vs TENS for the Treatment of Chemotherapy-Induced Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT02722434
- Acronym / sponsor ID
- MC15C1
- Conditions
- Pain, Peripheral Neuropathy, Tingling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 13 Apr 2016 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 26 Aug 2021 (actual)
- First posted
- 30 Mar 2016 (estimated)
- Results
- Posted 12 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (MC5-A scrambler therapy) | Experimental | Other: Laboratory Biomarker Analysis, Other: MC5-A Scrambler Therapy, Other: Questionnaire AdministrationPatients undergo MC5-A scrambler therapy over 30 minutes for 10 consecutive weekdays. |
| Arm II (TENS therapy) | Active comparator | Other: Laboratory Biomarker Analysis, Other: Questionnaire Administration, Other: Transcutaneous Electrical Nerve StimulationPatients undergo TENS therapy over 30 minutes daily for 14 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
- 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
Key exclusion criteria (15 listed)
- Any of the following:
- Existing operational implantable drug delivery systems, e.g. Medtronic Synchromed
- Existing implantable medical electronic devices, life-supporting medical devices, and medical monitoring 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laboratory Biomarker AnalysisCorrelative studies | Other | Arm I (MC5-A scrambler therapy), Arm II (TENS therapy) |
| MC5-A Scrambler TherapyAlso: Scrambler TherapyUndergo Scrambler therapy | Other | Arm I (MC5-A scrambler therapy) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (MC5-A scrambler therapy), Arm II (TENS therapy) |
| Transcutaneous Electrical Nerve StimulationAlso: TENS, transcutaneous electric nerve stimulationUndergo TENS | Other | Arm II (TENS therapy) |
Primary outcome
Number of Participants Who Achieve at Least a 50% Reduction in Their Primary Problematic Symptom (Either Pain or Tingling) From Baseline on Day 14
Time frame: Baseline to 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.
3 secondary outcomes
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
Time frame: At 10 weeks
Change in Sensory, Motor, and Autonomic Neuropathy Subscale Scores From Baseline to Week 10
Time frame: Up to 10 weeks
Number of Participants Using Acetaminophen as Pain Medication
Time frame: Up to 10 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33249081Childs 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.
- Derived from this study: PubMed 28257145Cathcart-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Loprinzi principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laboratory Biomarker Analysis, MC5-A Scrambler Therapy and Questionnaire Administration in people with Pain and Peripheral Neuropathy, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Baseline to Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02722434, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2022.