Trial Outcomes & Findings for Transcutaneous Electrical Nerve Stimulation (TENS) for Chemotherapy Induced Peripheral Neuropathy (CIPN) (NCT NCT06324344)

Last Updated: 2024-12-30

Results Overview

Pain was assessed using Item 9 of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30, version 3), which ranges from 1 ("not at all" experiencing pain) to 4 ("very much" experiencing pain). The percentage change from baseline to week 8 was reported, with negative values indicating a reduction in pain and positive values indicating an increase in pain.

Recruitment status

TERMINATED

Study phase

Target enrollment

10 participants

Primary outcome timeframe

baseline and 8 weeks

Results posted on

2024-12-30

Participant Flow

Participant milestones

Participant milestones
Measure	High-Dose TENS The intervention group will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy on a daily basis with a high-dose TENS device for 8 weeks. The high-dose TENS device elicits 1 hour of TENS per session. Subjects are instructed to complete at least 3 sessions per day. To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side on a weekly basis. High-Dose TENS: high-dose TENS device delivers 1 hour of TENS therapy per session.	Low-Dose TENS The Low-Dose TENS group will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy on a daily basis with a low-dose TENS device for 8 weeks. The low-dose TENS device is identical to the high-dose TENS device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes). Subjects are instructed to complete at least 3 sessions per day. To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side on a weekly basis. Low-Dose TENS: low-dose TENS device delivers 6 minutes of TENS therapy per session.
Overall Study STARTED	5	5
Overall Study COMPLETED	5	4
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Transcutaneous Electrical Nerve Stimulation (TENS) for Chemotherapy Induced Peripheral Neuropathy (CIPN)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Group n=5 Participants The intervention group will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy on a daily basis with a high-dose TENS device for 8 weeks. The high-dose TENS device elicits 1 hour of TENS per session. Subjects are instructed to complete at least 3 sessions per day. To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side on a weekly basis. High-Dose TENS: high-dose TENS device delivers 1 hour of TENS therapy per session.	Placebo Group n=4 Participants The placebo group will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy on a daily basis with a low-dose TENS device for 8 weeks. The low-dose TENS device is identical to the high-dose TENS device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes). Subjects are instructed to complete at least 3 sessions per day. To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side on a weekly basis. Low-Dose TENS: low-dose TENS device delivers 6 minutes of TENS therapy per session.	Total n=9 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Age, Continuous	57 years STANDARD_DEVIATION 11.70 • n=5 Participants	64 years STANDARD_DEVIATION 3.51 • n=7 Participants	60 years STANDARD_DEVIATION 9.62 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	3 Participants n=7 Participants	7 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	0 Participants n=5 Participants	1 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	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	2 Participants n=7 Participants	5 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
Region of Enrollment United States	5 participants n=5 Participants	4 participants n=7 Participants	9 participants n=5 Participants
Body Mass Index (BMI)	27 kg/m^2 STANDARD_DEVIATION 2.80 • n=5 Participants	38 kg/m^2 STANDARD_DEVIATION 7.26 • n=7 Participants	32 kg/m^2 STANDARD_DEVIATION 7.37 • n=5 Participants

PRIMARY outcome

Timeframe: baseline and 8 weeks

Outcome measures

Outcome measures
Measure	High-Dose TENS n=5 Participants The intervention group will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy on a daily basis with a high-dose TENS device for 8 weeks. The high-dose TENS device elicits 1 hour of TENS per session. Subjects are instructed to complete at least 3 sessions per day. To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side on a weekly basis. High-Dose TENS: high-dose TENS device delivers 1 hour of TENS therapy per session.	Low-Dose TENS n=4 Participants The Low-Dose TENS group will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy on a daily basis with a low-dose TENS device for 8 weeks. The low-dose TENS device is identical to the high-dose TENS device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes). Subjects are instructed to complete at least 3 sessions per day. To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side on a weekly basis. Low-Dose TENS: low-dose TENS device delivers 6 minutes of TENS therapy per session.
Change in Pain Level at 8 Weeks From Baseline	-18.33 Percent change Standard Deviation 15.28	25 Percent change Standard Deviation 0

SECONDARY outcome

Timeframe: week 8

Change in Vibration Perception Threshold (VPT) will be assessed using the Neuro Touch device (Yostra Labs, Bengaluru, Karnataka, India). Measurements will be taken on the big toe of the participants' left and right feet to determine the minimum vibration intensity required to perceive sensation. VPT values range from 0 to 50 volts, with higher values indicating greater numbness.

Outcome measures

Outcome measures
Measure	High-Dose TENS n=5 Participants The intervention group will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy on a daily basis with a high-dose TENS device for 8 weeks. The high-dose TENS device elicits 1 hour of TENS per session. Subjects are instructed to complete at least 3 sessions per day. To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side on a weekly basis. High-Dose TENS: high-dose TENS device delivers 1 hour of TENS therapy per session.	Low-Dose TENS n=4 Participants The Low-Dose TENS group will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy on a daily basis with a low-dose TENS device for 8 weeks. The low-dose TENS device is identical to the high-dose TENS device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes). Subjects are instructed to complete at least 3 sessions per day. To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side on a weekly basis. Low-Dose TENS: low-dose TENS device delivers 6 minutes of TENS therapy per session.
Vibration Perception Threshold at 8 Weeks Right foot	9.5 volts Standard Deviation 5.4	16.2 volts Standard Deviation 7.3
Vibration Perception Threshold at 8 Weeks Left foot	8.2 volts Standard Deviation 9.5	17.2 volts Standard Deviation 7.7

SECONDARY outcome

Timeframe: week 8

Quality of Life will be assessed using the European Organization for Research and Treatment in Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQC 30 ). It consists of 30 items divided into three main subscales: functional, symptom, and global health. Each subscale provides a comprehensive view of the patient's health and well-being. The Functional Scale measures physical, role, emotional, cognitive, and social functioning, with scores ranging from 0 to 100; higher scores indicate better functioning. The Symptom Scale evaluates cancer-related symptoms like fatigue, pain, and nausea, where higher scores (0-100) indicate greater symptom severity. The Global Health Scale assesses overall quality of life and general health, also scored from 0 to 100, with higher scores reflecting better health and well-being. These subscales provide critical insights for evaluating the impact of cancer and its treatment on patients.

Outcome measures

Outcome measures
Measure	High-Dose TENS n=5 Participants The intervention group will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy on a daily basis with a high-dose TENS device for 8 weeks. The high-dose TENS device elicits 1 hour of TENS per session. Subjects are instructed to complete at least 3 sessions per day. To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side on a weekly basis. High-Dose TENS: high-dose TENS device delivers 1 hour of TENS therapy per session.	Low-Dose TENS n=4 Participants The Low-Dose TENS group will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy on a daily basis with a low-dose TENS device for 8 weeks. The low-dose TENS device is identical to the high-dose TENS device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes). Subjects are instructed to complete at least 3 sessions per day. To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side on a weekly basis. Low-Dose TENS: low-dose TENS device delivers 6 minutes of TENS therapy per session.
Quality of Life at 8 Weeks Functional scale	72 score on a scale Standard Deviation 17.8	56 score on a scale Standard Deviation 24.3
Quality of Life at 8 Weeks Symptom scale	61 score on a scale Standard Deviation 25.04	57 score on a scale Standard Deviation 21.9
Quality of Life at 8 Weeks Global Health	33 score on a scale Standard Deviation 10.5	23 score on a scale Standard Deviation 7.2

OTHER_PRE_SPECIFIED outcome

Timeframe: week 8

Population: Only 2 subjects out of five in the High-Dose TENS group and three subjects out of 4 in the Low-Dose TENS group completed this test.

Sural nerve conduction velocity will be evaluated using the DPNCheck® device (Neurometrix, Woburn, MA, USA). The device is placed on the lateral portion of the patient's lower extremity and sends non-invasive electrical stimulation through the sural nerve to measure conduction velocity and amplitude. Conduction velocity is measured in meters per second (m/s), with normal values being greater than 40 m/s, while values below 40 m/s indicate slowed nerve signal transmission.

Outcome measures

Outcome measures
Measure	High-Dose TENS n=2 Participants The intervention group will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy on a daily basis with a high-dose TENS device for 8 weeks. The high-dose TENS device elicits 1 hour of TENS per session. Subjects are instructed to complete at least 3 sessions per day. To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side on a weekly basis. High-Dose TENS: high-dose TENS device delivers 1 hour of TENS therapy per session.	Low-Dose TENS n=3 Participants The Low-Dose TENS group will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy on a daily basis with a low-dose TENS device for 8 weeks. The low-dose TENS device is identical to the high-dose TENS device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes). Subjects are instructed to complete at least 3 sessions per day. To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side on a weekly basis. Low-Dose TENS: low-dose TENS device delivers 6 minutes of TENS therapy per session.
Sural Nerve Conduction Velocity at 8 Weeks	48 meters per second Standard Deviation 0	41.25 meters per second Standard Deviation 13.1

OTHER_PRE_SPECIFIED outcome

Timeframe: week 8

Population: Only 4 out of 5 participants in the High-Dose TENS group completed this test

Stride time will be measured utilizing wearable sensors (LEGSys, Biosensics, MA) placed on both ankles, thighs and waist. The patient will be asked to walk for 30 feet in a normal pace. The unit is second and higher values indicate slower gait.

Outcome measures

Outcome measures
Measure	High-Dose TENS n=4 Participants The intervention group will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy on a daily basis with a high-dose TENS device for 8 weeks. The high-dose TENS device elicits 1 hour of TENS per session. Subjects are instructed to complete at least 3 sessions per day. To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side on a weekly basis. High-Dose TENS: high-dose TENS device delivers 1 hour of TENS therapy per session.	Low-Dose TENS n=4 Participants The Low-Dose TENS group will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy on a daily basis with a low-dose TENS device for 8 weeks. The low-dose TENS device is identical to the high-dose TENS device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes). Subjects are instructed to complete at least 3 sessions per day. To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side on a weekly basis. Low-Dose TENS: low-dose TENS device delivers 6 minutes of TENS therapy per session.
Stride Time at 8 Weeks	1.11 seconds Standard Deviation .07	1.35 seconds Standard Deviation .34

OTHER_PRE_SPECIFIED outcome

Timeframe: week 8

Cadence will be measured utilizing wearable sensors (LegSys, Biosensics, MA) placed on both ankles, thighs and waist. The patient will be asked to walk for 30 feet in a normal pace. The number is steps per minute, higher values indicate faster speed.

Outcome measures

Outcome measures
Measure	High-Dose TENS n=4 Participants The intervention group will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy on a daily basis with a high-dose TENS device for 8 weeks. The high-dose TENS device elicits 1 hour of TENS per session. Subjects are instructed to complete at least 3 sessions per day. To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side on a weekly basis. High-Dose TENS: high-dose TENS device delivers 1 hour of TENS therapy per session.	Low-Dose TENS n=4 Participants The Low-Dose TENS group will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy on a daily basis with a low-dose TENS device for 8 weeks. The low-dose TENS device is identical to the high-dose TENS device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes). Subjects are instructed to complete at least 3 sessions per day. To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side on a weekly basis. Low-Dose TENS: low-dose TENS device delivers 6 minutes of TENS therapy per session.
Cadence at 8 Weeks	108 steps/min Standard Deviation 6.4	93 steps/min Standard Deviation 19.0

OTHER_PRE_SPECIFIED outcome

Timeframe: week 8

The double-support phase of gait will be measured utilizing wearable sensors (LEGSys, Biosensics, MA) placed on both ankles, thighs and waist. The patient will be asked to walk for 30 feet in a normal pace. The percentage of time the patient spends in the double support phase during the gait cycle will be recorded. Higher value indicates worst gait performance

Outcome measures

Outcome measures
Measure	High-Dose TENS n=4 Participants The intervention group will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy on a daily basis with a high-dose TENS device for 8 weeks. The high-dose TENS device elicits 1 hour of TENS per session. Subjects are instructed to complete at least 3 sessions per day. To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side on a weekly basis. High-Dose TENS: high-dose TENS device delivers 1 hour of TENS therapy per session.	Low-Dose TENS n=4 Participants The Low-Dose TENS group will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy on a daily basis with a low-dose TENS device for 8 weeks. The low-dose TENS device is identical to the high-dose TENS device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes). Subjects are instructed to complete at least 3 sessions per day. To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side on a weekly basis. Low-Dose TENS: low-dose TENS device delivers 6 minutes of TENS therapy per session.
Double-support Phase at 8 Weeks	22.0 percentage of gait cycle Standard Deviation 2.3	29.1 percentage of gait cycle Standard Deviation 15.9

OTHER_PRE_SPECIFIED outcome

Timeframe: week 8

Balance will be measured utilizing wearable sensors (BalaneSense, Biosensics, MA) placed on both ankles, thighs and waist. The patient will be asked to stand for 30 seconds with their eyes opened, then with their eyes closed. Center of Mass sway Area will be obtained from the hip and ankle motion. The unit is cm2 and higher value indicates poor balance. The center of mass sway was reported for eyes-closed condition.

Outcome measures

Outcome measures
Measure	High-Dose TENS n=4 Participants The intervention group will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy on a daily basis with a high-dose TENS device for 8 weeks. The high-dose TENS device elicits 1 hour of TENS per session. Subjects are instructed to complete at least 3 sessions per day. To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side on a weekly basis. High-Dose TENS: high-dose TENS device delivers 1 hour of TENS therapy per session.	Low-Dose TENS n=4 Participants The Low-Dose TENS group will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy on a daily basis with a low-dose TENS device for 8 weeks. The low-dose TENS device is identical to the high-dose TENS device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes). Subjects are instructed to complete at least 3 sessions per day. To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side on a weekly basis. Low-Dose TENS: low-dose TENS device delivers 6 minutes of TENS therapy per session.
Balance at 8 Weeks	.84 cm2 Standard Deviation .244	2.36 cm2 Standard Deviation 2.38

Adverse Events

Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Bijan Najafi

Baylor College of Medicine

Phone: 7137987536

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place