Trial Outcomes & Findings for Scrambler Therapy in the Treatment of Chronic Chemotherapy-Induced Peripheral Neuropathy (NCT NCT02111174)

Last Updated: 2018-08-17

Results Overview

To determine the change in pain from day 0 to day 28 (as measured by the Modified Brief Pain Index (BPI), question #3) with scrambler therapy in patients with chemotherapy induced peripheral neuropathy and pain (CIPN). The BPI short form is a pain assessment tool used with cancer patients to measure both severity of pain and interference caused by pain on 0-10 scales with higher scores indicating more pain. A negative score for the change in pain indicates improvement.

Recruitment status

COMPLETED

Study phase

Target enrollment

37 participants

Primary outcome timeframe

Change from baseline to 28 days

Results posted on

2018-08-17

Participant Flow

1 participant was consented and enrolled for training purposes only with the scrambler machine. This participant was not randomized into an arm and was not used in analysis.

Participant milestones

Participant milestones
Measure	Scrambler Therapy The device is a cutaneous electrical stimulator that uses electrodes placed on the skin similar to an electrocardiogram (EKG) machine, feeling similar to a tingling or bee-sting like sensation during the therapy. The electrodes are placed in areas thought to help relieve pain associated with chemotherapy-induced peripheral neuropathy. Scrambler Therapy	Sham Therapy The device is a cutaneous electrical stimulator that uses electrodes placed on the skin similar to an electrocardiogram (EKG) machine, feeling similar to a tingling or bee-sting like sensation during the therapy. The electrodes are placed in areas not thought to help relieve pain associated with chemotherapy-induced peripheral neuropathy. Sham Therapy
Treatment and Primary Outcome STARTED	18	18
Treatment and Primary Outcome COMPLETED	15	16
Treatment and Primary Outcome NOT COMPLETED	3	2
Secondary Outcomes (2 and 3 Month f/u) STARTED	15	16
Secondary Outcomes (2 and 3 Month f/u) 2 Month Follow up Complete	8	11
Secondary Outcomes (2 and 3 Month f/u) COMPLETED	7	9
Secondary Outcomes (2 and 3 Month f/u) NOT COMPLETED	8	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Scrambler Therapy The device is a cutaneous electrical stimulator that uses electrodes placed on the skin similar to an electrocardiogram (EKG) machine, feeling similar to a tingling or bee-sting like sensation during the therapy. The electrodes are placed in areas thought to help relieve pain associated with chemotherapy-induced peripheral neuropathy. Scrambler Therapy	Sham Therapy The device is a cutaneous electrical stimulator that uses electrodes placed on the skin similar to an electrocardiogram (EKG) machine, feeling similar to a tingling or bee-sting like sensation during the therapy. The electrodes are placed in areas not thought to help relieve pain associated with chemotherapy-induced peripheral neuropathy. Sham Therapy
Treatment and Primary Outcome Ineligible (not used in analysis)	1	0
Treatment and Primary Outcome Withdrawal by Subject	2	2
Secondary Outcomes (2 and 3 Month f/u) Lost to Follow-up	8	6
Secondary Outcomes (2 and 3 Month f/u) Death	0	1

Baseline Characteristics

Scrambler Therapy in the Treatment of Chronic Chemotherapy-Induced Peripheral Neuropathy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Scrambler Therapy n=18 Participants The device is a cutaneous electrical stimulator that uses electrodes placed on the skin similar to an electrocardiogram (EKG) machine, feeling similar to a tingling or bee-sting like sensation during the therapy. The electrodes are placed in areas thought to help relieve pain associated with chemotherapy-induced peripheral neuropathy. Scrambler Therapy	Sham Therapy n=18 Participants The device is a cutaneous electrical stimulator that uses electrodes placed on the skin similar to an electrocardiogram (EKG) machine, feeling similar to a tingling or bee-sting like sensation during the therapy. The electrodes are placed in areas not thought to help relieve pain associated with chemotherapy-induced peripheral neuropathy. Sham Therapy	Total n=36 Participants Total of all reporting groups
Age, Continuous	59.71 years STANDARD_DEVIATION 8.88 • n=5 Participants	58.94 years STANDARD_DEVIATION 9.31 • n=7 Participants	59.31 years STANDARD_DEVIATION 8.97 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	15 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants	18 Participants n=7 Participants	36 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 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	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	10 Participants n=7 Participants	22 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Baseline Pain Score	6.29 units on a scale STANDARD_DEVIATION 1.9 • n=5 Participants	6.83 units on a scale STANDARD_DEVIATION 1.62 • n=7 Participants	6.57 units on a scale STANDARD_DEVIATION 1.75 • n=5 Participants
Using opioids at baseline or during treatment	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Using neuroleptics at baseline or during treatment	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Sensory subscale score at baseline	13.47 units on a scale STANDARD_DEVIATION 5.73 • n=5 Participants	15.83 units on a scale STANDARD_DEVIATION 4.49 • n=7 Participants	14.69 units on a scale STANDARD_DEVIATION 5.19 • n=5 Participants
Motor subscale score at baseline	10.53 units on a scale STANDARD_DEVIATION 5.21 • n=5 Participants	11.83 units on a scale STANDARD_DEVIATION 5.09 • n=7 Participants	11.2 units on a scale STANDARD_DEVIATION 5.12 • n=5 Participants

PRIMARY outcome

Timeframe: Change from baseline to 28 days

Population: Data was analyzed from 17/18 participants in Arm 1 since one was deemed ineligible in retrospect.

Outcome measures

Outcome measures
Measure	Sham Therapy n=18 Participants The device is a cutaneous electrical stimulator that uses electrodes placed on the skin similar to an electrocardiogram (EKG) machine, feeling similar to a tingling or bee-sting like sensation during the therapy. The electrodes are placed in areas not thought to help relieve pain associated with chemotherapy-induced peripheral neuropathy. Sham Therapy	Scrambler Therapy n=17 Participants The device is a cutaneous electrical stimulator that uses electrodes placed on the skin similar to an electrocardiogram (EKG) machine, feeling similar to a tingling or bee-sting like sensation during the therapy. The electrodes are placed in areas thought to help relieve pain associated with chemotherapy-induced peripheral neuropathy. Scrambler Therapy
Change in Pain as Measured by the Modified Brief Pain Index at 28 Days	-1.06 units on a scale Standard Deviation 2.32	-0.5 units on a scale Standard Deviation 1.2

SECONDARY outcome

Timeframe: Change from baseline to 2 months

To determine the change in pain from day 0 to 2 months (as measured by the Modified Brief Pain Index (BPI), question #3) with scrambler therapy in patients with chemotherapy induced peripheral neuropathy and pain (CIPN). The BPI short form is a pain assessment tool used with cancer patients to measure both severity of pain and interference caused by pain on 0-10 scales with higher scores indicating more pain. A negative score for the change in pain indicates improvement.

Outcome measures

Outcome measures
Measure	Sham Therapy n=16 Participants The device is a cutaneous electrical stimulator that uses electrodes placed on the skin similar to an electrocardiogram (EKG) machine, feeling similar to a tingling or bee-sting like sensation during the therapy. The electrodes are placed in areas not thought to help relieve pain associated with chemotherapy-induced peripheral neuropathy. Sham Therapy	Scrambler Therapy n=15 Participants The device is a cutaneous electrical stimulator that uses electrodes placed on the skin similar to an electrocardiogram (EKG) machine, feeling similar to a tingling or bee-sting like sensation during the therapy. The electrodes are placed in areas thought to help relieve pain associated with chemotherapy-induced peripheral neuropathy. Scrambler Therapy
Change in Pain at 2 Months as Measured by the Modified Brief Pain Index	-0.25 units on a scale Standard Deviation 0.92	-0.31 units on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: Change from baseline to 3 months

To determine the change in pain from day 0 to 3 months (as measured by the Modified Brief Pain Index (BPI), question #3) with scrambler therapy in patients with chemotherapy induced peripheral neuropathy and pain (CIPN). The BPI short form is a pain assessment tool used with cancer patients to measure both severity of pain and interference caused by pain on 0-10 scales with higher scores indicating more pain. A negative score for the change in pain indicates improvement.

Outcome measures

Outcome measures
Measure	Sham Therapy n=16 Participants The device is a cutaneous electrical stimulator that uses electrodes placed on the skin similar to an electrocardiogram (EKG) machine, feeling similar to a tingling or bee-sting like sensation during the therapy. The electrodes are placed in areas not thought to help relieve pain associated with chemotherapy-induced peripheral neuropathy. Sham Therapy	Scrambler Therapy n=15 Participants The device is a cutaneous electrical stimulator that uses electrodes placed on the skin similar to an electrocardiogram (EKG) machine, feeling similar to a tingling or bee-sting like sensation during the therapy. The electrodes are placed in areas thought to help relieve pain associated with chemotherapy-induced peripheral neuropathy. Scrambler Therapy
Change in Pain at 3 Months as Measured by the Modified Brief Pain Index	-0.44 units on a scale Standard Deviation 1.12	-0.75 units on a scale Standard Deviation 1.78

SECONDARY outcome

Timeframe: Change from baseline to 28 days

Population: Data was analyzed from 17/18 participants in Arm 1 since one was deemed ineligible in retrospect.

This was assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-CIPN20, a CIPN-specific questionnaire which includes two scales assessing sensory and motor symptoms and functioning with each question measured on a 0-3 scale. For sensory there are 9 questions with a total score range from 0-27 with higher scores indicating more bothersome symptoms. A negative change in score indicates improvement in symptoms.

Outcome measures

Outcome measures
Measure	Sham Therapy n=18 Participants The device is a cutaneous electrical stimulator that uses electrodes placed on the skin similar to an electrocardiogram (EKG) machine, feeling similar to a tingling or bee-sting like sensation during the therapy. The electrodes are placed in areas not thought to help relieve pain associated with chemotherapy-induced peripheral neuropathy. Sham Therapy	Scrambler Therapy n=17 Participants The device is a cutaneous electrical stimulator that uses electrodes placed on the skin similar to an electrocardiogram (EKG) machine, feeling similar to a tingling or bee-sting like sensation during the therapy. The electrodes are placed in areas thought to help relieve pain associated with chemotherapy-induced peripheral neuropathy. Scrambler Therapy
Changes in Patient Reported Sensory Outcomes at 28 Days	-4.67 units on a scale Standard Deviation 6.66	-4.76 units on a scale Standard Deviation 6.69

SECONDARY outcome

Timeframe: Change from baseline to 2 months

Outcome measures

Outcome measures
Measure	Sham Therapy n=16 Participants The device is a cutaneous electrical stimulator that uses electrodes placed on the skin similar to an electrocardiogram (EKG) machine, feeling similar to a tingling or bee-sting like sensation during the therapy. The electrodes are placed in areas not thought to help relieve pain associated with chemotherapy-induced peripheral neuropathy. Sham Therapy	Scrambler Therapy n=15 Participants The device is a cutaneous electrical stimulator that uses electrodes placed on the skin similar to an electrocardiogram (EKG) machine, feeling similar to a tingling or bee-sting like sensation during the therapy. The electrodes are placed in areas thought to help relieve pain associated with chemotherapy-induced peripheral neuropathy. Scrambler Therapy
Changes in Patient Reported Sensory Outcomes at 2 Months	-8.39 units on a scale Standard Deviation 8.37	-8.94 units on a scale Standard Deviation 9.33

SECONDARY outcome

Timeframe: Change from baseline to 3 months

Outcome measures

Outcome measures
Measure	Sham Therapy n=16 Participants The device is a cutaneous electrical stimulator that uses electrodes placed on the skin similar to an electrocardiogram (EKG) machine, feeling similar to a tingling or bee-sting like sensation during the therapy. The electrodes are placed in areas not thought to help relieve pain associated with chemotherapy-induced peripheral neuropathy. Sham Therapy	Scrambler Therapy n=15 Participants The device is a cutaneous electrical stimulator that uses electrodes placed on the skin similar to an electrocardiogram (EKG) machine, feeling similar to a tingling or bee-sting like sensation during the therapy. The electrodes are placed in areas thought to help relieve pain associated with chemotherapy-induced peripheral neuropathy. Scrambler Therapy
Changes in Patient Reported Sensory Outcomes at 3 Months	-11.39 units on a scale Standard Deviation 7.84	-9.62 units on a scale Standard Deviation 9.22

SECONDARY outcome

Timeframe: Change from baseline to 28 days

Population: Data was analyzed from 17/18 participants in Arm 1 since one was deemed ineligible in retrospect.

This will be assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-CIPN20, a CIPN-specific questionnaire which includes two scales assessing sensory and motor symptoms and functioning with each question measured on a 0-3 scale. For motor there are 8 questions with a total score range from 0-24 with higher scores indicating more bothersome symptoms. A negative change in score indicates improvement in symptoms.

Outcome measures

Outcome measures
Measure	Sham Therapy n=18 Participants The device is a cutaneous electrical stimulator that uses electrodes placed on the skin similar to an electrocardiogram (EKG) machine, feeling similar to a tingling or bee-sting like sensation during the therapy. The electrodes are placed in areas not thought to help relieve pain associated with chemotherapy-induced peripheral neuropathy. Sham Therapy	Scrambler Therapy n=17 Participants The device is a cutaneous electrical stimulator that uses electrodes placed on the skin similar to an electrocardiogram (EKG) machine, feeling similar to a tingling or bee-sting like sensation during the therapy. The electrodes are placed in areas thought to help relieve pain associated with chemotherapy-induced peripheral neuropathy. Scrambler Therapy
Changes in Patient Reported Motor Outcomes at 28 Days	-2.83 units on a scale Standard Deviation 6.35	-2.97 units on a scale Standard Deviation 6.49

SECONDARY outcome

Timeframe: Change from baseline to 2 months

Outcome measures

Outcome measures
Measure	Sham Therapy n=16 Participants The device is a cutaneous electrical stimulator that uses electrodes placed on the skin similar to an electrocardiogram (EKG) machine, feeling similar to a tingling or bee-sting like sensation during the therapy. The electrodes are placed in areas not thought to help relieve pain associated with chemotherapy-induced peripheral neuropathy. Sham Therapy	Scrambler Therapy n=15 Participants The device is a cutaneous electrical stimulator that uses electrodes placed on the skin similar to an electrocardiogram (EKG) machine, feeling similar to a tingling or bee-sting like sensation during the therapy. The electrodes are placed in areas thought to help relieve pain associated with chemotherapy-induced peripheral neuropathy. Scrambler Therapy
Changes in Patient Reported Motor Outcomes at 2 Months	-5.67 units on a scale Standard Deviation 6.59	-5.88 units on a scale Standard Deviation 7.27

SECONDARY outcome

Timeframe: Change from baseline to 3 months

Outcome measures

Outcome measures
Measure	Sham Therapy n=16 Participants The device is a cutaneous electrical stimulator that uses electrodes placed on the skin similar to an electrocardiogram (EKG) machine, feeling similar to a tingling or bee-sting like sensation during the therapy. The electrodes are placed in areas not thought to help relieve pain associated with chemotherapy-induced peripheral neuropathy. Sham Therapy	Scrambler Therapy n=15 Participants The device is a cutaneous electrical stimulator that uses electrodes placed on the skin similar to an electrocardiogram (EKG) machine, feeling similar to a tingling or bee-sting like sensation during the therapy. The electrodes are placed in areas thought to help relieve pain associated with chemotherapy-induced peripheral neuropathy. Scrambler Therapy
Changes in Patient Reported Motor Outcomes at 3 Months	-8.53 units on a scale Standard Deviation 7.28	-6.62 units on a scale Standard Deviation 6.59

SECONDARY outcome

Timeframe: 28 days post-intervention

Population: Data was analyzed from 17/18 participants in Arm 1 since one was deemed ineligible in retrospect.

This will be assessed by concomitant medication review by a study team member during the 10 days of treatment. Follow-up was assessed as participant self-report over the last 10 days; all opiates were further tabulated using a morphine oral dose equivalents table to allow better comparison between patients and arms.

Outcome measures

Outcome measures
Measure	Sham Therapy n=18 Participants The device is a cutaneous electrical stimulator that uses electrodes placed on the skin similar to an electrocardiogram (EKG) machine, feeling similar to a tingling or bee-sting like sensation during the therapy. The electrodes are placed in areas not thought to help relieve pain associated with chemotherapy-induced peripheral neuropathy. Sham Therapy	Scrambler Therapy n=17 Participants The device is a cutaneous electrical stimulator that uses electrodes placed on the skin similar to an electrocardiogram (EKG) machine, feeling similar to a tingling or bee-sting like sensation during the therapy. The electrodes are placed in areas thought to help relieve pain associated with chemotherapy-induced peripheral neuropathy. Scrambler Therapy
Number of Patients Who Stopped Using Opioids at 28 Days	1 Participants	3 Participants

SECONDARY outcome

Timeframe: 28 days post-intervention

Population: Data was analyzed from 17/18 participants in Arm 1 since one was deemed ineligible in retrospect.

Outcome measures

Outcome measures
Measure	Sham Therapy n=18 Participants The device is a cutaneous electrical stimulator that uses electrodes placed on the skin similar to an electrocardiogram (EKG) machine, feeling similar to a tingling or bee-sting like sensation during the therapy. The electrodes are placed in areas not thought to help relieve pain associated with chemotherapy-induced peripheral neuropathy. Sham Therapy	Scrambler Therapy n=17 Participants The device is a cutaneous electrical stimulator that uses electrodes placed on the skin similar to an electrocardiogram (EKG) machine, feeling similar to a tingling or bee-sting like sensation during the therapy. The electrodes are placed in areas thought to help relieve pain associated with chemotherapy-induced peripheral neuropathy. Scrambler Therapy
Number of Patients Who Stopped Using Neuroleptics at 28 Days	0 Participants	1 Participants

Adverse Events

Scrambler Therapy

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Sham Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Scrambler Therapy n=18 participants at risk The device is a cutaneous electrical stimulator that uses electrodes placed on the skin similar to an electrocardiogram (EKG) machine, feeling similar to a tingling or bee-sting like sensation during the therapy. The electrodes are placed in areas thought to help relieve pain associated with chemotherapy-induced peripheral neuropathy. Scrambler Therapy	Sham Therapy n=18 participants at risk The device is a cutaneous electrical stimulator that uses electrodes placed on the skin similar to an electrocardiogram (EKG) machine, feeling similar to a tingling or bee-sting like sensation during the therapy. The electrodes are placed in areas not thought to help relieve pain associated with chemotherapy-induced peripheral neuropathy. Sham Therapy
Surgical and medical procedures Surgical and medical procedures - other, specify	5.6% 1/18 • Number of events 1 • Adverse events were collected up to 3 months after participants initiated treatment. AEs were self reported by participants as they occurred and collected between the time participants initiated treatment to the time they completed all treatment and follow up on the study at 3 months.	0.00% 0/18 • Adverse events were collected up to 3 months after participants initiated treatment. AEs were self reported by participants as they occurred and collected between the time participants initiated treatment to the time they completed all treatment and follow up on the study at 3 months.

Additional Information

Thomas Smith, M.D.

Johns Hopkins SKCCC

Phone: 410-955-2091

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place