Back to resultsMC5-A Scrambler Therapy or TENS Therapy in Treating Patients With Chemotherapy-Induced Peripheral Neuropathy
Primary Purpose
Pain, Peripheral Neuropathy, Tingling
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Laboratory Biomarker Analysis
MC5-A Scrambler Therapy
Questionnaire Administration
Transcutaneous Electrical Nerve Stimulation
Sponsored by
About this trial
This is an interventional supportive care trial for Pain
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
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm I (MC5-A scrambler therapy)
Arm II (TENS therapy)
Arm Description
Patients undergo MC5-A scrambler therapy over 30 minutes for 10 consecutive weekdays.
Patients undergo TENS therapy over 30 minutes daily for 14 days.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Number of Participants Using Acetaminophen as Pain Medication
The number of participants using acetaminophen as pain medication is reported below.
Full Information
NCT ID
NCT02722434
First Posted
March 23, 2016
Last Updated
December 23, 2021
Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT02722434
Brief Title
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
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
April 13, 2016 (Actual)
Primary Completion Date
September 1, 2017 (Actual)
Study Completion Date
August 26, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Peripheral Neuropathy, Tingling
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm I (MC5-A scrambler therapy)
Arm Type
Experimental
Arm Description
Patients undergo MC5-A scrambler therapy over 30 minutes for 10 consecutive weekdays.
Arm Title
Arm II (TENS therapy)
Arm Type
Active Comparator
Arm Description
Patients undergo TENS therapy over 30 minutes daily for 14 days.
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
MC5-A Scrambler Therapy
Other Intervention Name(s)
Scrambler Therapy
Intervention Description
Undergo Scrambler therapy
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Transcutaneous Electrical Nerve Stimulation
Other Intervention Name(s)
TENS, transcutaneous electric nerve stimulation
Intervention Description
Undergo TENS
Primary Outcome Measure Information:
Title
Number of Participants Who Achieve at Least a 50% Reduction in Their Primary Problematic Symptom (Either Pain or Tingling) From Baseline on Day 14
Description
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
Secondary Outcome Measure Information:
Title
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
Description
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
Title
Change in Sensory, Motor, and Autonomic Neuropathy Subscale Scores From Baseline to Week 10
Description
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
Title
Number of Participants Using Acetaminophen as Pain Medication
Description
The number of participants using acetaminophen as pain medication is reported below.
Time Frame
Up to 10 weeks
Other Pre-specified Outcome Measures:
Title
Change in mRNA Gene Expression
Description
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
Title
Change in Functional MRI (fMRI)
Description
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
Title
Change in Sensation
Description
Descriptive statistics will be used for the data from Quantitative Sensory Testing.
Time Frame
Baseline to up to 10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Loprinzi
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33249081
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.
Results Reference
derived
PubMed Identifier
28257145
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.
Results Reference
derived
Learn more about this trial
MC5-A Scrambler Therapy or TENS Therapy in Treating Patients With Chemotherapy-Induced Peripheral Neuropathy
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