Trial Outcomes & Findings for MC5-A Scrambler Therapy in Reducing Peripheral Neuropathy Caused by Chemotherapy (NCT NCT01290224)

NCT ID: NCT01290224

Last Updated: 2014-03-05

Results Overview

CIPN measurement items score range: 0 (none) to 10 (as bad as can be). The questions assessed the intensity of numbness, tingling, or pain in toes or feet that patients have had right now, at its worst over the past 24 hours, and on average over the past 24 hours.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 10 participants
• Primary outcome timeframe: On days 1 and 2
• Results posted on: 2014-03-05

Participant Flow

Ten (10) participants were recruited at Mayo Clinic between February 2011 and April 2011. All 10 participants have completed sham procedure (day 1) and proceed to scrambler treatment (day 2 to 11).

Participant milestones

Measure	Sham Procedure + Scrambler Treatment
Overall Study STARTED	10
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	Sham Procedure + Scrambler Treatment
Overall Study Adverse Event	1
Overall Study Refused Further Treatment	4

Baseline Characteristics

MC5-A Scrambler Therapy in Reducing Peripheral Neuropathy Caused by Chemotherapy

Baseline characteristics by cohort

Measure	Sham Procedure + Scrambler Treatment n=10 Participants
Age, Continuous	55.2 years STANDARD_DEVIATION 9.8 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants
Number of neurotoxic agents exposed to Single Agent	7 participants n=5 Participants
Number of neurotoxic agents exposed to Multiple Agents	3 participants n=5 Participants
Duration of pain symptoms at baseline <=6 months	10 participants n=5 Participants
Duration of pain symptoms at baseline >6 months	0 participants n=5 Participants

PRIMARY outcome

Timeframe: On days 1 and 2

CIPN measurement items score range: 0 (none) to 10 (as bad as can be). The questions assessed the intensity of numbness, tingling, or pain in toes or feet that patients have had right now, at its worst over the past 24 hours, and on average over the past 24 hours.

Outcome measures

Measure	Sham Procedure + Scrambler Treatment n=10 Participants	Scrambler Therapy (Day 2)
Percentage of Patients Who Have at Least a 50% Reduction (i.e., Success) in at Least 1 of the First 12 Chemotherapy Induced Peripheral Neuropathy (CIPN) Measurement Questions in the Pre/Post Therapy Questionnaire Sham Procedure	60 Percentage of Participants	—
Percentage of Patients Who Have at Least a 50% Reduction (i.e., Success) in at Least 1 of the First 12 Chemotherapy Induced Peripheral Neuropathy (CIPN) Measurement Questions in the Pre/Post Therapy Questionnaire Scrambler Therapy	50 Percentage of Participants	—

SECONDARY outcome

Timeframe: On days 1 and 2

The 12 CIPN symptoms individual question range: 0 (none) to 10 (as bad as can be). The questions assessed the intensity of numbness, tingling, or pain in toes or feet that patients have had right now (RN), at its worst over the past 24 hours (WP24H), and on average over the past 24 hours (AvgP24H). Averaged change between day 1 and day 2 across 10 patients was calculated.

Outcome measures

Measure	Sham Procedure + Scrambler Treatment n=10 Participants	Scrambler Therapy (Day 2) n=10 Participants
Average Change of CIPN Symptoms Between Sham Procedure and Scrambler Therapy as Measured by Each Individual Question Numbness, tingling, or pain in toes/feet RN	-1 units on a scale Standard Deviation 1.49	-0.2 units on a scale Standard Deviation 1.62
Average Change of CIPN Symptoms Between Sham Procedure and Scrambler Therapy as Measured by Each Individual Question Numbness in toes/feet RN	-0.8 units on a scale Standard Deviation 1.40	-0.5 units on a scale Standard Deviation 0.85
Average Change of CIPN Symptoms Between Sham Procedure and Scrambler Therapy as Measured by Each Individual Question Tingling in toes/feet RN	-0.8 units on a scale Standard Deviation 1.32	-0.8 units on a scale Standard Deviation 1.55
Average Change of CIPN Symptoms Between Sham Procedure and Scrambler Therapy as Measured by Each Individual Question Pain in toes/feet RN	0 units on a scale Standard Deviation 1.41	0.1 units on a scale Standard Deviation 1.60
Average Change of CIPN Symptoms Between Sham Procedure and Scrambler Therapy as Measured by Each Individual Question Numbness, tingling, or pain in toes/feet at WP24H	-0.7 units on a scale Standard Deviation 1.25	0 units on a scale Standard Deviation 0.94
Average Change of CIPN Symptoms Between Sham Procedure and Scrambler Therapy as Measured by Each Individual Question Numbness in toes/feet at WP24H	-0.6 units on a scale Standard Deviation 1.35	-0.7 units on a scale Standard Deviation 0.82
Average Change of CIPN Symptoms Between Sham Procedure and Scrambler Therapy as Measured by Each Individual Question Tingling in toes/feet at WP24H	-0.7 units on a scale Standard Deviation 0.95	-0.2 units on a scale Standard Deviation 0.42
Average Change of CIPN Symptoms Between Sham Procedure and Scrambler Therapy as Measured by Each Individual Question Pain in toes/feet at WP24H	0.1 units on a scale Standard Deviation 0.74	0.2 units on a scale Standard Deviation 1.40
Average Change of CIPN Symptoms Between Sham Procedure and Scrambler Therapy as Measured by Each Individual Question Numbness, tingling, or pain in toes/feet AvgP24H	-0.4 units on a scale Standard Deviation 0.70	-0.6 units on a scale Standard Deviation 2.27
Average Change of CIPN Symptoms Between Sham Procedure and Scrambler Therapy as Measured by Each Individual Question Numbness in toes/feet AvgP24H	-0.6 units on a scale Standard Deviation 1.17	-0.8 units on a scale Standard Deviation 1.32
Average Change of CIPN Symptoms Between Sham Procedure and Scrambler Therapy as Measured by Each Individual Question Tingling in toes/feet AvgP24H	-0.1 units on a scale Standard Deviation 1.45	-0.2 units on a scale Standard Deviation 1.14
Average Change of CIPN Symptoms Between Sham Procedure and Scrambler Therapy as Measured by Each Individual Question Pain in toes/feet AvgP24H	-0.3 units on a scale Standard Deviation 1.77	-0.2 units on a scale Standard Deviation 1.03

SECONDARY outcome

Timeframe: Day 1 and Day 10

The 12 CIPN symptoms individual question range: 0 (none) to 10 (as bad as can be). The questions assessed the intensity of numbness, tingling, or pain in toes or feet that patients have had right now (RN), at its worst over the past 24 hours (WP24H), and on average over the past 24 hours (AvgP24H).

Outcome measures

Measure	Sham Procedure + Scrambler Treatment n=10 Participants	Scrambler Therapy (Day 2)
Percentage of Reduction at Days 10 From Day 1 in Each of the 12 CIPN Measurement Questions in the Daily Therapy Questionnaire Numbness, tingling, or pain in toes/feet RN	43.5 percentage of reduction in symptom Standard Deviation 41.7	—
Percentage of Reduction at Days 10 From Day 1 in Each of the 12 CIPN Measurement Questions in the Daily Therapy Questionnaire Numbness in toes/feet RN	46.7 percentage of reduction in symptom Standard Deviation 36.3	—
Percentage of Reduction at Days 10 From Day 1 in Each of the 12 CIPN Measurement Questions in the Daily Therapy Questionnaire Tingling in toes/feet RN	37.8 percentage of reduction in symptom Standard Deviation 57.7	—
Percentage of Reduction at Days 10 From Day 1 in Each of the 12 CIPN Measurement Questions in the Daily Therapy Questionnaire Pain in toes/feet RN	13.4 percentage of reduction in symptom Standard Deviation 89.3	—
Percentage of Reduction at Days 10 From Day 1 in Each of the 12 CIPN Measurement Questions in the Daily Therapy Questionnaire Numbness, tingling, or pain in toes/feet at WP24H	12.8 percentage of reduction in symptom Standard Deviation 52.0	—
Percentage of Reduction at Days 10 From Day 1 in Each of the 12 CIPN Measurement Questions in the Daily Therapy Questionnaire Numbness in toes/feet at WP24H	40.6 percentage of reduction in symptom Standard Deviation 37.5	—
Percentage of Reduction at Days 10 From Day 1 in Each of the 12 CIPN Measurement Questions in the Daily Therapy Questionnaire Tingling in toes/feet at WP24H	50.6 percentage of reduction in symptom Standard Deviation 47.6	—
Percentage of Reduction at Days 10 From Day 1 in Each of the 12 CIPN Measurement Questions in the Daily Therapy Questionnaire Pain in toes/feet at WP24H (Worsen)	-8.3 percentage of reduction in symptom Standard Deviation 99.1	—
Percentage of Reduction at Days 10 From Day 1 in Each of the 12 CIPN Measurement Questions in the Daily Therapy Questionnaire Numbness, tingling or pain in toes/feet AvgP24H	23.5 percentage of reduction in symptom Standard Deviation 27.9	—
Percentage of Reduction at Days 10 From Day 1 in Each of the 12 CIPN Measurement Questions in the Daily Therapy Questionnaire Numbness in toes/feet AvgP24H	45.2 percentage of reduction in symptom Standard Deviation 32.2	—
Percentage of Reduction at Days 10 From Day 1 in Each of the 12 CIPN Measurement Questions in the Daily Therapy Questionnaire Tingling in toes/feet AvgP24H	48.4 percentage of reduction in symptom Standard Deviation 46.8	—
Percentage of Reduction at Days 10 From Day 1 in Each of the 12 CIPN Measurement Questions in the Daily Therapy Questionnaire Pain in toes/feet AvgP24H	26.6 percentage of reduction in symptom Standard Deviation 70.8	—

SECONDARY outcome

Timeframe: Week 1 and Week 10

The NCCTG peripheral neuropathy question range: 0 (No numbness or tingling or pain in fingers and/or toes) to 10 (Numbness, tingling or pain in fingers and/pr toes as bad as you can imagine). The question assessed the intensity of numbness, tingling or pain in toes or feet in the past week.

Outcome measures

Measure	Sham Procedure + Scrambler Treatment n=10 Participants	Scrambler Therapy (Day 2)
Percentage of Reduction at Weeks 10 From Week 1 in CIPN Symptoms as Measured by the North Central Cancer Treatment Group (NCCTG) Peripheral Neuropathy Question	3.2 percentage of reduction in symptom Standard Deviation 38.6	—

SECONDARY outcome

Timeframe: Day 1 and Week 10

The intensity of symptom was measured in a likert scale: none at all (0), a little bit (1), quite a bit (2) and very much (3). Percent change from day 1 at week 10 for each patient was calculated and average of percentage was reported.

Outcome measures

Measure	Sham Procedure + Scrambler Treatment n=10 Participants	Scrambler Therapy (Day 2)
Percent Change From Day 1 at Week 10 in CIPN Symptom Bother as Measured by 8 CIPN Symptom Questions Tingling in toes/feet	42.9 percentage of a scale Standard Deviation 45.0	—
Percent Change From Day 1 at Week 10 in CIPN Symptom Bother as Measured by 8 CIPN Symptom Questions Numbness in toes/feet	-25.0 percentage of a scale Standard Deviation 46.3	—
Percent Change From Day 1 at Week 10 in CIPN Symptom Bother as Measured by 8 CIPN Symptom Questions Shooting/burning in toes/feet	-10.0 percentage of a scale Standard Deviation 89.4	—
Percent Change From Day 1 at Week 10 in CIPN Symptom Bother as Measured by 8 CIPN Symptom Questions Problems standing/walking	21.4 percentage of a scale Standard Deviation 39.3	—
Percent Change From Day 1 at Week 10 in CIPN Symptom Bother as Measured by 8 CIPN Symptom Questions Cramps in toes/feet	50.0 percentage of a scale Standard Deviation 44.7	—
Percent Change From Day 1 at Week 10 in CIPN Symptom Bother as Measured by 8 CIPN Symptom Questions Difficulty walking	16.7 percentage of a scale Standard Deviation 25.8	—
Percent Change From Day 1 at Week 10 in CIPN Symptom Bother as Measured by 8 CIPN Symptom Questions Difficulty with stairs	20.0 percentage of a scale Standard Deviation 27.4	—
Percent Change From Day 1 at Week 10 in CIPN Symptom Bother as Measured by 8 CIPN Symptom Questions Difficulty using car foot pedals	20.0 percentage of a scale Standard Deviation 44.7	—

SECONDARY outcome

Timeframe: Day 1 to Day 10

CTCAE Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death.

Outcome measures

Measure	Sham Procedure + Scrambler Treatment n=10 Participants	Scrambler Therapy (Day 2)
Toxicity (Other Than CIPN) Profile Associated With Scrambler Therapy as Measured by Common Terminology Criteria for Adverse Events (CTCAE) 4.0 Grade 1, 2	1 participants	—
Toxicity (Other Than CIPN) Profile Associated With Scrambler Therapy as Measured by Common Terminology Criteria for Adverse Events (CTCAE) 4.0 Grade 3, 4, 5	0 participants	—

SECONDARY outcome

Timeframe: On days 1-11 and for 10 weeks after therapy

Outcome measures

Measure	Sham Procedure + Scrambler Treatment n=10 Participants	Scrambler Therapy (Day 2)
Analgesic Use Over Time Tylenol	3 participants	—
Analgesic Use Over Time Ibuprofen	3 participants	—
Analgesic Use Over Time Cymbalta	1 participants	—
Analgesic Use Over Time Lyrica	1 participants	—
Analgesic Use Over Time Tramadol	1 participants	—
Analgesic Use Over Time Gabapentin	1 participants	—
Analgesic Use Over Time Acetaminophen	2 participants	—
Analgesic Use Over Time Oxycontin	1 participants	—
Analgesic Use Over Time Oxycodone	1 participants	—

Adverse Events

Sham Procedure + Scrambler Treatment

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Sham Procedure + Scrambler Treatment n=10 participants at risk
Musculoskeletal and connective tissue disorders Musculoskeletal/connective tissue disorder - achiness, fatigue and heaviness in bilateral lower legs	10.0% 1/10 • Number of events 1 • 11 days NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was utilized for AE reporting. The adverse event: musculoskeletal/connective tissue disorder was reported on day 3, which is during the scrambler treatment period.

Additional Information

Dr. Charles L. Loprinzi

Mayo Clinic

Phone: 507-284-2511

Email: cloprinzi@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place