Trial Outcomes & Findings for MC5-A Scrambler Therapy or TENS Therapy in Treating Patients With Chemotherapy-Induced Peripheral Neuropathy (NCT NCT02722434)

Last Updated: 2022-01-12

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

50 participants

Primary outcome timeframe

Baseline to Day 14

Results posted on

2022-01-12

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I (MC5-A Scrambler Therapy) Patients undergo MC5-A scrambler therapy over 30 minutes for 10 consecutive weekdays.	Arm II (TENS Therapy) Patients undergo TENS therapy over 30 minutes daily for 14 days.
Overall Study STARTED	25	25
Overall Study Started Treatment	24	25
Overall Study COMPLETED	24	22
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm I (MC5-A Scrambler Therapy) Patients undergo MC5-A scrambler therapy over 30 minutes for 10 consecutive weekdays.	Arm II (TENS Therapy) Patients undergo TENS therapy over 30 minutes daily for 14 days.
Overall Study Withdrawal Prior to Beginning Treatment	1	0
Overall Study Withdrawal After Beginning Treatment	0	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (MC5-A Scrambler Therapy) n=25 Participants Patients undergo MC5-A scrambler therapy over 30 minutes for 10 consecutive weekdays.	Arm II (TENS Therapy) n=25 Participants Patients undergo TENS therapy over 30 minutes daily for 14 days.	Total n=50 Participants Total of all reporting groups
Age, Continuous	61.0 years n=5 Participants	61.0 years n=7 Participants	61.0 years n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	17 Participants n=7 Participants	34 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants	24 Participants n=7 Participants	45 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
ECOG Performance Status 0	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants
ECOG Performance Status 1	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
ECOG Performance Status 2	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Day 14

Population: All Participants

Outcome measures

Outcome measures
Measure	Arm I (MC5-A Scrambler Therapy) n=25 Participants Patients undergo MC5-A scrambler therapy over 30 minutes for 10 consecutive weekdays.	Arm II (TENS Therapy) n=25 Participants Patients undergo TENS therapy over 30 minutes daily for 14 days.
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 Participants	5 Participants

SECONDARY outcome

Timeframe: At 10 weeks

Population: Participants who completed the SGIC 'Therapy recommendation to other patients with similar problems' item at Week 10 are included in this analysis.

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.

Outcome measures

Outcome measures
Measure	Arm I (MC5-A Scrambler Therapy) n=21 Participants Patients undergo MC5-A scrambler therapy over 30 minutes for 10 consecutive weekdays.	Arm II (TENS Therapy) n=17 Participants Patients undergo TENS therapy over 30 minutes daily for 14 days.
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 No	0 Participants	7 Participants
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 Yes	16 Participants	7 Participants
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 Unsure	5 Participants	3 Participants

SECONDARY outcome

Timeframe: Up to 10 weeks

Population: Participants who completed all subscale items from the EORTC QLQ CIPN-20 at baseline and Week 10 are included in this analysis.

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.

Outcome measures

Outcome measures
Measure	Arm I (MC5-A Scrambler Therapy) n=25 Participants Patients undergo MC5-A scrambler therapy over 30 minutes for 10 consecutive weekdays.	Arm II (TENS Therapy) n=25 Participants Patients undergo TENS therapy over 30 minutes daily for 14 days.
Change in Sensory, Motor, and Autonomic Neuropathy Subscale Scores From Baseline to Week 10 Sensory Subscale	-0.4 score on a scale Interval -2.4 to 0.1	-0.6 score on a scale Interval -1.4 to 0.3
Change in Sensory, Motor, and Autonomic Neuropathy Subscale Scores From Baseline to Week 10 Motor Subscale	-0.1 score on a scale Interval -1.5 to 0.5	-0.3 score on a scale Interval -1.7 to 0.3
Change in Sensory, Motor, and Autonomic Neuropathy Subscale Scores From Baseline to Week 10 Autonomic Subscale	0.0 score on a scale Interval -1.0 to 0.3	0.0 score on a scale Interval -1.0 to 0.5

SECONDARY outcome

Timeframe: Up to 10 weeks

Population: All Participants

The number of participants using acetaminophen as pain medication is reported below.

Outcome measures

Outcome measures
Measure	Arm I (MC5-A Scrambler Therapy) n=25 Participants Patients undergo MC5-A scrambler therapy over 30 minutes for 10 consecutive weekdays.	Arm II (TENS Therapy) n=25 Participants Patients undergo TENS therapy over 30 minutes daily for 14 days.
Number of Participants Using Acetaminophen as Pain Medication	8 Participants	9 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to up to 10 weeks

In a descriptive manner, the gene expression will be compared to what was previously reported by Starkweather et al.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to up to 10 weeks

Changes in fMRI following Scrambler therapy will be described in the subset of patients selected for this component of the study.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to up to 10 weeks

Descriptive statistics will be used for the data from Quantitative Sensory Testing.

Outcome measures

Outcome data not reported

Adverse Events

Arm I (MC5-A Scrambler Therapy)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm II (TENS Therapy)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Arm I (MC5-A Scrambler Therapy) n=24 participants at risk Patients undergo MC5-A scrambler therapy over 30 minutes for 10 consecutive weekdays.	Arm II (TENS Therapy) n=25 participants at risk Patients undergo TENS therapy over 30 minutes daily for 14 days.
Injury, poisoning and procedural complications Fracture	0.00% 0/24 • Up to 10 weeks Participants who completed the study and did not withdraw prior to starting treatment are evaluable for adverse events.	4.0% 1/25 • Number of events 1 • Up to 10 weeks Participants who completed the study and did not withdraw prior to starting treatment are evaluable for adverse events.

Additional Information

Charles L Loprinzi MD

Mayo Clinic

Phone: 507/284-2511

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place