Not provided
Not provided
Not provided
Not provided
Not provided
The PI moved to another institution
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| NeuroMetrix, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The purpose of this pilot study is to examine the acceptability and proof of concept effectiveness of a wireless Transcutaneous Electrical Nerve Stimulation (TENS) technology to address Chemotherapy Induced Peripheral Neuropathy (CIPN). Participants, who satisfy the inclusion and exclusion criteria and sign the informed consent form will be randomly assigned with ratio of 1:1 into two groups. The patients and clinicians will be blinded for group allocation. One group will utilize TENS high-dose devices (Intervention group, IG); the other group will utilize low-dose TENS devices (Placebo group, PG). The baseline measurements will be performed, and the patients will take the programmed device home for a duration of 8 weeks. Then, the patients will come back after four weeks (4W) and after 8 weeks (8W) for outcome assessment. The primary outcome will be pain. Secondary outcomes include: nerve conduction and velocity, vibration perception threshold, quality of life. Exploratory outcomes include gait assessment (gait speed, stride length, double stance, and gait steadiness), and balance.
Chemotherapy and other cancer treatments can cause damage to the peripheral nerves mainly reflected in severe pain in the upper and/or lower extremities. Additional to pain, cancer treatment may cause loss of balance which affects motor capacity and is a major cause of poor quality of life. There are only minimally effective treatments for CIPN despite over 20 years of research. Few recent studies have suggested that exercise intervention could be effective to restore numbness and motor capacity loss because of CIPN. Unfortunately, conventional rehabilitation programs however suffer from poor adherence and those programs for supervised settings have limitation of access for those who live in the remote areas (e.g., rural area), or could be too frail to travel after chemotherapy. This raised a significant disparity for delivering an effective therapy for those who are living in remote areas or those who are too frail to travel. Therefore, will test Quell® Transcutaneous Electrical Nerve Stimulation device developed by Neurometrix Inc. (Woburn, MA, USA), to mitigate the associated symptoms caused by CIPN. This device utilizes a wireless technology manageable through a smart phone application (Quell App) that also tracks symptom-status.
The investigators institution, Duncan Cancer Center (McNair Campus, Baylor College of Medicine St Luke's, Houston, Texas, USA) supervised by specialists in clinical and surgical oncology, has a high volume of patients that present with CIPN. Therefore, the investigators believe that this institution is a suitable place to perform this sub-study. The premise of this sub-study is that daily basis of TENS therapy could be effective to reduce pain, reduce numbness and improve both motor-capacity and mobility performance leading to improve quality of life in those who suffer from CIPN and have limited access to health care.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Active Comparator | 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. |
|
| Placebo Group | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-Dose TENS | Device | high-dose TENS device delivers 1 hour of TENS therapy per session. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Level at 8 Weeks From Baseline | 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. | baseline and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Vibration Perception Threshold at 8 Weeks | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Sural Nerve Conduction Velocity at 8 Weeks | 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. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Pain Level at 8 Weeks From Baseline | 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. | Posted | Mean | Standard Deviation | Percent change | baseline and 8 weeks |
|
8 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bijan Najafi | Baylor College of Medicine | 7137987536 | bijan.najafi@bcm.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 7, 2024 | Aug 7, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 9, 2024 | Aug 7, 2024 | ICF_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
Not provided
Not provided
Participants who satisfy the inclusion and exclusion criteria and sign the informed consent form will be randomly assigned into two groups in a 1:1 ratio. One group will utilize high-dose TENS therapy (Intervention group, AG); the other group will utilize low-dose TENS devices (Placebo group, PG).
Both groups will receive their respective devices at the initial visit (Baseline) and will be asked to return in 4 weeks and 8 weeks for follow-up assessment.
Throughout this 8-week period the participants may receive follow-up phone calls assessing their compliance. All subjects will keep their active device after completion of the 8-week study.
Not provided
Not provided
Double
| Low-Dose TENS | Device | low-dose TENS device delivers 6 minutes of TENS therapy per session. |
|
|
| week 8 |
| Quality of Life at 8 Weeks | 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. | week 8 |
| week 8 |
| Stride Time at 8 Weeks | 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. | week 8 |
| Cadence at 8 Weeks | 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. | week 8 |
| Double-support Phase at 8 Weeks | 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 | week 8 |
| Balance at 8 Weeks | 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. | week 8 |
| BG001 | Placebo Group | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| OG001 | 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. |
|
|
| Secondary | Vibration Perception Threshold at 8 Weeks | 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. | Posted | Mean | Standard Deviation | volts | week 8 |
|
|
|
| Secondary | Quality of Life at 8 Weeks | 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. | Posted | Mean | Standard Deviation | score on a scale | week 8 |
|
|
|
| Other Pre-specified | Sural Nerve Conduction Velocity at 8 Weeks | 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. | 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. | Posted | Mean | Standard Deviation | meters per second | week 8 |
|
|
|
| Other Pre-specified | Stride Time at 8 Weeks | 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. | Only 4 out of 5 participants in the High-Dose TENS group completed this test | Posted | Mean | Standard Deviation | seconds | week 8 |
|
|
|
| Other Pre-specified | Cadence at 8 Weeks | 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. | Posted | Mean | Standard Deviation | steps/min | week 8 |
|
|
|
| Other Pre-specified | Double-support Phase at 8 Weeks | 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 | Posted | Mean | Standard Deviation | percentage of gait cycle | week 8 |
|
|
|
| Other Pre-specified | Balance at 8 Weeks | 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. | Posted | Mean | Standard Deviation | cm2 | week 8 |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Placebo Group | 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. | 0 | 5 | 0 | 5 | 0 | 5 |
Not provided
Not provided
| D000698 |
| Analgesia |
| D000760 | Anesthesia and Analgesia |
| Global Health |
|