Peripheral NeuropathyNCT05357469
Innovative Treatment of Chemotherapy-Induced Painful Peripheral Neuropathy in Adolescents and Young Adults With Cancer: A Two Arm Pilot Study
A study testing Immediate St (Scrambler Therapy) and Waitlist ST (Scrambler Therapy) in people with Peripheral Neuropathy, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To evaluate the efficacy and safety of Scrambler therapy (ST) for chemotherapy-induced painful peripheral neuropathy (CIPN), and the impact of ST on physical functioning and quality of life (QoL) in adolescents and young adults (AYA) cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Neuropathy
- What is being tested?
- Immediate St (Scrambler Therapy) and Waitlist ST (Scrambler Therapy)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2022to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- - Both genders aged 15-39 years
- - Patients who have CIPN associated with at least moderate symptoms of pain (≥4 on a 0-10 scale) or neuropathy.
- - Patients have had cancer and are not being actively treated,
- - Patients who speaks English and able to complete questionnaires by themselves or with help from parents and/or nurses. Written informed consent will be obtained from adults (aged 18-39 years) or from parents/guardians of adolescents (aged 15-17 years) and assent will be obtained from adolescents (aged 15-17 years) under an Institutional Review Board (IRB)-approved protocol.
Who cannot join
- - Inability to walk or stand without assistance (need for ambulatory-assist devices)
- - Bone and/or central nervous system metastases that affect gait, walking and balance
- - History of other known or unknown causes of acute or chronic neuropathic and/or no neuropathic pain conditions.
- - Implanted intrathecal drug-delivery system or a spinal cord and/or peripheral nerve stimulator;
- a metal implant such as a cardiac pacemaker, automatic defibrillator, aneurysm clips, vena cava clips, or skull plate.
- - History of epilepsy.
- - Skin damage at the site of electrode placement; and i) prior ST treatment; j) Patients on pain medications for other than CIPN.
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the efficacy and safety of Scrambler therapy (ST) for chemotherapy-induced painful peripheral neuropathy (CIPN), and the impact of ST on physical functioning and quality of life (QoL) in adolescents and young adults (AYA) cancer patients.
In this proposed study, we will conduct a two-arm prospective, randomized wait-list controlled clinical trial to investigate the effectiveness of ST on pain and CIPN in AYAs with cancer.
Read the detailed description
Baseline Visit:
If you agree to take part in this study, you will have a Baseline Visit (a visit done before you begin receiving ST). At this visit:
You will have a physical exam. You will complete questionnaires about your symptoms, pain levels and how you think pain is affecting your life (such as your mood, ability to work, enjoyment of life, relationships with other people, and so on), quality of life, and your ability to walk and sleep. These questionnaires should take less than 30 minutes to complete. You will be asked about your pain medication use (including the name of the medications and how often you use them). You will complete a 6-Minute Walk Test. For this test, you will be asked to walk back and forth over a short distance as many times as you can for 6 minutes. This helps researchers measure your physical ability to walk and how well you can walk. You will have a sensory test to help researchers measure your touch sensation and your pain threshold for warm and cold temperatures. This test should take about 1 hour.
Study Groups and Scrambler Therapy:
After your Baseline Visit, you will be randomly assigned to 1 of 2 groups: Immediate ST or Waitlist ST. This is done because no one knows if one group is better, the same, or worse than the other. In Immediate ST, you will start ST treatment right away. In Waitlist ST, you will start ST treatment about 4 weeks after your Baseline Visit. You will have an equal chance (50/50) of being assigned to either group. The study staff will tell you which group you are in and when you will start treatment. You will receive Scrambler Therapy one (1) time a day, Monday through Friday, for up to 2 weeks (a total of 10 ST treatments). During each ST treatment session, about 2-10 pads, called electrodes, will be placed on your legs/feet or wrist/hands where you are experiencing pain, tingling, and/or numbness. A small electrical current will then be sent to the electrodes. At each session, you will receive the current for about 30-45 minutes.
Study Visits
Before each ST:
You will complete questionnaires about your pain levels and how you think pain is affecting your life, as well as the questionnaire about your ability to walk and sleep. These should take about 5-10 minutes to complete. copies You will be asked about your pain medication use.
At each ST session:
You will have a physical exam. You will have a sensory test.
Every week for 4 weeks after ST is complete, you will complete questionnaires about your pain levels and how you think pain is affecting your life, as well as the questionnaire about your ability to walk and sleep. You will also be asked about your pain medication use.
At Months 1, 2, and 3 after ST:
You will have a physical exam. You will have a sensory test. You will complete questionnaires about your pain levels and how you think pain is affecting your life, as well as the questionnaire about your ability to walk and sleep. You will be asked about your pain medication use.
At the Month 3 visit only:
You will complete the questionnaire about your quality of life. You will complete a 6 Minute Walk Test. Your participation in this study will be over after the 3-month visit
- Conditions
- Peripheral Neuropathy
- Being tested
- Immediate St (Scrambler Therapy), Waitlist ST (Scrambler Therapy)
- Medical subject headings
- Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate St (Scrambler Therapy)Device
Participant will receive Scrambler Therapy one (1) time a day, Monday through Friday, for up to 2 weeks (a total of 10 ST treatments).
Waitlist ST (Scrambler Therapy)Device
Participant will receive Scrambler Therapy one (1) time a day, Monday through Friday, for up to 2 weeks (a total of 10 ST treatments).
| Study group | Role | What they receive |
|---|---|---|
| Immediate St (Scrambler Therapy) | Experimental | Participant will start ST (Scrambler Therapy) treatment right away. Receives: Device: Immediate St (Scrambler Therapy) |
| Waitlist ST (Scrambler Therapy) | Experimental | Participant will start ST (Scrambler Therapy) treatment about 4 weeks after your Baseline Visit. Receives: Device: Waitlist ST (Scrambler Therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The European Organization for Research and Treatment of Cancer ( EORTC-QLQ C30)
Five functional scales (physical, role, cognitive, emotional, and social); nine symptom scales (fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation, diarrhea, and financial difficulties); and a global health status/QoL. Based on 30 questions in total, the scores range from 0 to 100.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start14 Jul 2022
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Salahadin Abdi, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05357469
- Sponsor's protocol ID
- 2021-0657
- Other IDs
- NCI-2022-03832, 1R21CA256136-01A1
- Status last verified
- Jul 2026
- First submitted
- 27 Apr 2022
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Treatment of Chemotherapy-Induced Painful Peripheral Neuropathy in Adolescents and Young Adults With Cancer: A Two Arm Pilot Study
- ClinicalTrials.gov ID
- NCT05357469
- Acronym / sponsor ID
- 2021-0657
- Conditions
- Peripheral Neuropathy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- 14 Jul 2022 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy and safety of Scrambler therapy (ST) for chemotherapy-induced painful peripheral neuropathy (CIPN), and the impact of ST on physical functioning and quality of life (QoL) in adolescents and young adults (AYA) cancer patients.
In this proposed study, we will conduct a two-arm prospective, randomized wait-list controlled clinical trial to investigate the effectiveness of ST on pain and CIPN in AYAs with cancer.
Detailed description
Baseline Visit:
If you agree to take part in this study, you will have a Baseline Visit (a visit done before you begin receiving ST). At this visit:
You will have a physical exam. You will complete questionnaires about your symptoms, pain levels and how you think pain is affecting your life (such as your mood, ability to work, enjoyment of life, relationships with other people, and so on), quality of life, and your ability to walk and sleep. These questionnaires should take less than 30 minutes to complete. You will be asked about your pain medication use (including the name of the medications and how often you use them). You will complete a 6-Minute Walk Test. For this test, you will be asked to walk back and forth over a short distance as many times as you can for 6 minutes. This helps researchers measure your physical ability to walk and how well you can walk. You will have a sensory test to help researchers measure your touch sensation and your pain threshold for warm and cold temperatures. This test should take about 1 hour.
Study Groups and Scrambler Therapy:
After your Baseline Visit, you will be randomly assigned to 1 of 2 groups: Immediate ST or Waitlist ST. This is done because no one knows if one group is better, the same, or worse than the other. In Immediate ST, you will start ST treatment right away. In Waitlist ST, you will start ST treatment about 4 weeks after your Baseline Visit. You will have an equal chance (50/50) of being assigned to either group. The study staff will tell you which group you are in and when you will start treatment. You will receive Scrambler Therapy one (1) time a day, Monday through Friday, for up to 2 weeks (a total of 10 ST treatments). During each ST treatment session, about 2-10 pads, called electrodes, will be placed on your legs/feet or wrist/hands where you are experiencing pain, tingling, and/or numbness. A small electrical current will then be sent to the electrodes. At each session, you will receive the current for about 30-45 minutes.
Study Visits
Before each ST:
You will complete questionnaires about your pain levels and how you think pain is affecting your life, as well as the questionnaire about your ability to walk and sleep. These should take about 5-10 minutes to complete. copies You will be asked about your pain medication use.
At each ST session:
You will have a physical exam. You will have a sensory test.
Every week for 4 weeks after ST is complete, you will complete questionnaires about your pain levels and how you think pain is affecting your life, as well as the questionnaire about your ability to walk and sleep. You will also be asked about your pain medication use.
At Months 1, 2, and 3 after ST:
You will have a physical exam. You will have a sensory test. You will complete questionnaires about your pain levels and how you think pain is affecting your life, as well as the questionnaire about your ability to walk and sleep. You will be asked about your pain medication use.
At the Month 3 visit only:
You will complete the questionnaire about your quality of life. You will complete a 6 Minute Walk Test. Your participation in this study will be over after the 3-month visit
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate St (Scrambler Therapy) | Experimental | Device: Immediate St (Scrambler Therapy)Participant will start ST (Scrambler Therapy) treatment right away. |
| Waitlist ST (Scrambler Therapy) | Experimental | Device: Waitlist ST (Scrambler Therapy)Participant will start ST (Scrambler Therapy) treatment about 4 weeks after your Baseline Visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- - Both genders aged 15-39 years
- - Patients who have CIPN associated with at least moderate symptoms of pain (≥4 on a 0-10 scale) or neuropathy.
- - Patients have had cancer and are not being actively treated,
- - Patients who speaks English and able to complete questionnaires by themselves or with help from parents and/or nurses. Written informed consent will be obtained from adults (aged 18-39 years) or from parents/guardians of adolescents (aged 15-17 years) and assent will be obtained from adolescents (aged 15-17 years) under an Institutional Review Board (IRB)-approved protocol.
Key exclusion criteria (7 listed)
- - Inability to walk or stand without assistance (need for ambulatory-assist devices)
- - Bone and/or central nervous system metastases that affect gait, walking and balance
- - History of other known or unknown causes of acute or chronic neuropathic and/or no neuropathic pain conditions.
- - Implanted intrathecal drug-delivery system or a spinal cord and/or peripheral nerve stimulator;
- - History of epilepsy.
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 |
|---|---|---|
| Immediate St (Scrambler Therapy)Participant will receive Scrambler Therapy one (1) time a day, Monday through Friday, for up to 2 weeks (a total of 10 ST treatments). | Device | Immediate St (Scrambler Therapy) |
| Waitlist ST (Scrambler Therapy)Participant will receive Scrambler Therapy one (1) time a day, Monday through Friday, for up to 2 weeks (a total of 10 ST treatments). | Device | Waitlist ST (Scrambler Therapy) |
Primary outcome
The European Organization for Research and Treatment of Cancer ( EORTC-QLQ C30)
Time frame: through study completion, an average of 1 year
Five functional scales (physical, role, cognitive, emotional, and social); nine symptom scales (fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation, diarrhea, and financial difficulties); and a global health status/QoL. Based on 30 questions in total, the scores range from 0 to 100.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
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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.
Salahadin Abdi, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate St (Scrambler Therapy) and Waitlist ST (Scrambler Therapy) in people with Peripheral Neuropathy, run by M.D. Anderson Cancer Center 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 4 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 8 Jul 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
The European Organization for Research and Treatment of Cancer ( EORTC-QLQ C30) (time frame: through study completion, an average of 1 year). 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 8 Jul 2026.