Chemotherapy-induced Peripheral NeuropathyNCT06324344
Transcutaneous Electrical Nerve Stimulation (TENS) for Chemotherapy Induced Peripheral Neuropathy (CIPN)
A study testing High-Dose TENS and Low-Dose TENS in people with Chemotherapy-induced Peripheral Neuropathy and Pain, run by Baylor College of Medicine at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy, Pain, Neuropathy
- What is being tested?
- High-Dose TENS and Low-Dose TENS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2023to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥ 18 years old willing and able to participate in study.
- Able to use an app via smart phone.
- Patients with Chemotherapy Induced Peripheral Neuropathy (CIPN) grades II and III.
- Have undergone chemotherapy with a drug known to cause neurotoxicity.
- Have finished chemotherapy ≥1 month, and still experiences CIPN.
Who cannot join
- Pregnancy or Lactation.
- Nerve Block a week prior to enrollment.
- Peripheral Sensory Neuropathy Grade I and IV.
- Patients applying ointments to the lower extremities.
- Patients with electrical implanted devices such as pacemakers.
- Patients with lower extremity wounds/history of minor/major amputation.
- Planning to undergo any type of chemotherapy in the next 3 months.
- Neuropathy derived from uncontrolled Diabetes Mellitus.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcutaneous Electrical Nerve Stimulation for Lower Extremity in Patients With Neurogenic Pain - A Proof Concept Randomized Clinical Trial
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.
Read the detailed description
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.
- Conditions
- Chemotherapy-induced Peripheral Neuropathy, Pain, Neuropathy
- Being tested
- High-Dose TENS, Low-Dose TENS
- Keywords
- Transcutaneous Electrical Nerve Stimulation, Quell
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Dose TENSDevice
Also called High Dose TENS, Active
high-dose TENS device delivers 1 hour of TENS therapy per session.
Low-Dose TENSDevice
Also called Placebo
low-dose TENS device delivers 6 minutes of TENS therapy per session.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: High-Dose TENS |
| 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. Receives: Device: Low-Dose TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 8 weeks
Secondary outcomes (2)
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.
Measured: 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.
Measured: week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start2 Oct 2023
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Why it stopped: The PI moved to another institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chemotherapy-induced Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- NeuroMetrix, Inc.
- Responsible party
- Principal investigator, Bijan Najafi, PhD, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06324344
- Sponsor's protocol ID
- H-50753-B
- Status last verified
- Dec 2024
- First submitted
- 15 Mar 2024
- Last updated
- 30 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Electrical Nerve Stimulation for Lower Extremity in Patients With Neurogenic Pain - A Proof Concept Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06324344
- Acronym / sponsor ID
- H-50753-B
- Conditions
- Chemotherapy-induced Peripheral Neuropathy, Pain, Neuropathy
- Keywords
- Transcutaneous Electrical Nerve Stimulation, Quell
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The PI moved to another institution
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- NeuroMetrix, Inc.
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 21 Mar 2024 (actual)
- Results
- Posted 30 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Active comparator | Device: High-Dose TENSThe 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 | Device: Low-Dose TENSThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults ≥ 18 years old willing and able to participate in study.
- Able to use an app via smart phone.
- Patients with Chemotherapy Induced Peripheral Neuropathy (CIPN) grades II and III.
- Have undergone chemotherapy with a drug known to cause neurotoxicity.
- Have finished chemotherapy ≥1 month, and still experiences CIPN.
Key exclusion criteria (8 listed)
- Pregnancy or Lactation.
- Nerve Block a week prior to enrollment.
- Peripheral Sensory Neuropathy Grade I and IV.
- Patients applying ointments to the lower extremities.
- Patients with electrical implanted devices such as pacemakers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Dose TENSAlso: High Dose TENS, Activehigh-dose TENS device delivers 1 hour of TENS therapy per session. | Device | Intervention Group |
| Low-Dose TENSAlso: Placebolow-dose TENS device delivers 6 minutes of TENS therapy per session. | Device | Placebo Group |
Primary outcome
Change in Pain Level at 8 Weeks From Baseline
Time frame: baseline and 8 weeks
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.
2 secondary outcomes
Vibration Perception Threshold at 8 Weeks
Time frame: week 8
Quality of Life at 8 Weeks
Time frame: week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Chemotherapy-induced Peripheral Neuropathy
Active, not recruiting
The AIUR Trial: Surgical Gloves to Prevent Peripheral Neuropathy
Chemotherapy-induced Peripheral Neuropathy
Not yet recruiting
Continuous Controlled Cooling for Prevention of Chemotherapy-Induced Peripheral Neuropathy
Chemotherapy Induced Peripheral Neuropathy (CIPN)
RecruitingObservational study
Relationship Between Great Toe Strength And Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Chemotherapy-induced Peripheral Neuropathy (CIPN), Healthy
Not yet recruiting
The Effect of Aerobic and Resistance Training With and Without Neurodynamic Exercises on Chemotherapy-induced Peripheral Neuropathy Symptoms and Associated Neuro-immune Mechanisms
Chemotherapy Induced Peripheral Neuropathy (CIPN)
RecruitingEarly Phase 1
Neuroprotective Potential of Cannabidiol (CBD) in Preventing Oxaliplatin (Ox)-Induced Neuropathy
Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients, Metastatic Colorectal Cancer (CRC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Dose TENS and Low-Dose TENS in people with Chemotherapy-induced Peripheral Neuropathy and Pain, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Level at 8 Weeks From Baseline (time frame: baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2024.