Chemotherapy-induced Peripheral NeuropathyNCT07219472
Scrambler Therapy for Chemotherapy-Induced Peripheral Neuropathy
A study testing Scrambler Therapy in people with Chemotherapy-induced Peripheral Neuropathy and CIPN - Chemotherapy-Induced Peripheral Neuropathy, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
This research study is for people who have a condition called chemotherapy-induced peripheral neuropathy (CIPN). This condition develops as a result of receiving medication(s) to treat cancer, particularly chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy, CIPN - Chemotherapy-Induced Peripheral Neuropathy
- What is being tested?
- Scrambler Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2026to Dec 2027
- 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
- Adults with CIPN-related pain for at least three months duration, and for which the participant wants intervention
- At least three months from the last dose of neurotoxic cancer-directed drug
- No plan (at the time of study enrollment) for additional neurotoxic cancer-directed therapies for at least five months after trial enrollment
- Pain rated ≥ four out of 10 in severity (0-10 pain scale) during the seven days prior to enrollment
- > Six-month life expectancy
- Able to complete questionnaires by themselves or with assistance
Show all 9Show fewer
- Able to provide informed written consent
- ECOG Performance Status score ≥ two
- Not currently enrolled in another research study for pain or neuropathy
Who cannot join
- Pregnant or nursing
- An operational implanted drug delivery system, implanted electronic medical device, life supporting medical device, and/or medical monitoring device
- History of myocardial infarction or ischemic heart disease within six months of trial enrollment
- History of epilepsy, brain damage resulting in seizure activity, or use of anticonvulsants for seizure
- Skin conditions such as open sores that will prevent proper application of electrodes
- Unwillingness or inability to wean and discontinue gabapentin or pregabalin prior to the start of ST
Show all 9Show fewer
- History of symptomatic peripheral neuropathy prior to receiving neurotoxic chemotherapy
- Prior treatment with Scrambler Therapy
- The presence of chronic regional pain syndrome (CRPS) in the scrambler therapy treatment area.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Case Comprehensive Cancer Center, Cleveland Clinic Foundation Taussig Cancer Institute
Cleveland, Ohio, 44195
Laura Shoemaker, DO, MS, FAAHPM, (216) 444-5193, shoemal@ccf.org
Laura Shoemaker, DO, MS, FAAHPM
About this study
Official title: A Randomized, Single-Blind, Sham-Controlled Study of Scrambler Therapy for Chemotherapy-Induced Peripheral Neuropathy
This research study is for people who have a condition called chemotherapy-induced peripheral neuropathy (CIPN). This condition develops as a result of receiving medication(s) to treat cancer, particularly chemotherapy. CIPN is characterized by pain, numbness, tingling or burning sensations, typically in the hands and feet of people. These symptoms can lead to physical suffering, limited ability to perform daily activities, and low quality of life. One of the ways to treat CIPN is using a device called Scrambler Therapy. Scrambler Therapy was approved by the Food and Drug Administration (FDA) in 2009 as a treatment for CIPN. The treatment involves electrical signals passing through wires attached to parts of the body via adhesive tabs near where symptoms of CIPN are experienced. A standard treatment course consists of 10 daily sessions lasting about one hour each. The purpose of this study is to determine the effect of a 10-day course of Scrambler Therapy on symptoms of chemotherapy-induced peripheral neuropathy, day-to-day activities, overall quality of life, and use of pain medications. Participants will be randomly assigned to one of two groups. One group will receive Scrambler Therapy. The other group will not receive it. Participants will not know which group they were in until after treatment has completed. Participants in the group who did not receive Scrambler Therapy will have the opportunity to receive it after one month. Participants will be in this research study about 12 to 14 months.
Read the detailed description
Neuropathy is damage or disease affecting the somatosensory nervous system. It can result in pain, numbness and other feelings of tingling or burning on the skin. Neuropathic pain often does not go away for a long time, which can negatively impact quality of life. Even though neuropathic pain comes from the nervous system, it is often managed with medications.
In recent years, Scrambler Therapy (ST) has come up as a way to treat neuropathic pain that does not use medications. ST was approved by the FDA in 2009 to treat neuropathic pain. It works by replacing or overriding pain signals and rewires the way that people may perceive pain. It was originally designed to treat cancer pain. A standard course of ST consists of ten daily sessions over two consecutive weeks. Treatment may stop early if participants no longer report feeling neuropathic pain.
Previous research on the effects of ST for neuropathic pain have shown positive findings with very few participants reporting negative side effects of ST treatment. However, there are some limitations of ST, including the time and cost of the treatment, limited availability of ST, and the necessary skills needed to administer it.
ST is a promising solution to pain caused by CIPN. CIPN occurs in 30-40% of people treated with chemotherapy. CIPN can sometimes cause interruptions in cancer treatment and negatively impact quality of life. The amount of people with CIPN may also rise as more people with cancer live longer. Due to this, it is important to explore ST as a treatment for CIPN. This study aims to investigate the short-term and long-term impacts of ST as an alternative to medication treatments for CIPN.
- Conditions
- Chemotherapy-induced Peripheral Neuropathy, CIPN - Chemotherapy-Induced Peripheral Neuropathy
- Being tested
- Scrambler Therapy, Sham/No Intervention
- Keywords
- Scrambler therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scrambler TherapyDevice
Participants will attend 10 consecutive weekday 45-minute sessions of scrambler therapy.
Sham/No InterventionOther
Participants will be blinded as to which arm they are in (experimental vs. sham comparator), and as such, participants in the sham comparator arm will attend 10 consecutive weekday 45-minute sessions of sham scrambler therapy. In the sham comparator arm, participants will NOT receive a therapeutic level of scrambler therapy.
| Study group | Role | What they receive |
|---|---|---|
| Scrambler Therapy | Experimental | Not described Receives: Device: Scrambler Therapy |
| Sham Scrambler Therapy | Sham comparator | Not described Receives: Other: Sham/No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in participant-reported pain
Participant-reported pain is measured by the Severity of Neuropathic Symptoms, in which participants rank their pain on a scale of 0 (Not at All) to 10 (Severe). Higher scores indicate greater pain symptoms.
Measured: Baseline, end of treatment (up to 14 days)
Secondary outcomes (4)
Change in participant-reported non-pain neuropathic symptoms
Participant-reported non-pain neuropathic symptoms are measured by the Severity of Neuropathic Symptoms, in which participants rank their symptoms on a scale of 0 (Not at All) to 10 (Severe) for the following areas: numbness, tingling, cold sensation, warm sensation, stiffness, swelling, and pruritus. Higher scores indicate greater symptoms.
Measured: Baseline, end of treatment (up to 14 days)
Change in functional status
Functional status is measured by the Functional Well-Being subscale of the Functional Assessment of Cancer Therapy - General (FACT-G) (version 4). This subscale contains 7 items, which participants will rank their functional status for each item on a 5-point scale of 0 (Not at all) to 4 (Very much). Lower scores indicate greater functional status.
Measured: Baseline, end of treatment (up to 14 days)
Change in quality of life
Quality of life is measured by the Functional Assessment of Cancer Therapy - General (FACT-G) (version 4). It is a 27-item questionnaire with four subscales (physical well-being, social/family well-being, emotional well-being, and functional well-being). Participants answer questions on a 5-point scale from 0 (Not all all) to 4 (Very much). Lower scores indicate greater quality of life.
Measured: Baseline, end of treatment (up to 14 days)
Change in participant-perceived treatment efficacy
Participant-perceived treatment efficacy is measured by the Patient Global Impression of Change, which is a single-item measure. Participants rank their belief about treatment efficacy on a 7-point scale from "Very much improved" to "Very much worse." Scores in the "improved" qualitative items indicate a greater perceived treatment efficacy.
Measured: Baseline, end of treatment (up to 14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2025
- Study start27 Mar 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy-induced Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Case Comprehensive 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- VelaSano
- Responsible party
- Sponsor
- Investigators
- Laura Shoemaker, DO, MS, FAAHPM, Principal investigator, Case Comprehensive Cancer Center, Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07219472
- Sponsor's protocol ID
- CASE3Y25
- Status last verified
- Aug 2026
- First submitted
- 20 Oct 2025
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Finnerup NB, Kuner R, Jensen TS. Neuropathic Pain: From Mechanisms to Treatment. Physiol Rev. 2021 Jan 1;101(1):259-301. doi: 10.1152/physrev.00045.2019. Epub 2020 Jun 25.
PubMed 32584191Szok D, Tajti J, Nyari A, Vecsei L. Therapeutic Approaches for Peripheral and Central Neuropathic Pain. Behav Neurol. 2019 Nov 21;2019:8685954. doi: 10.1155/2019/8685954. eCollection 2019.
PubMed 31871494Moisset X, Bouhassira D, Avez Couturier J, Alchaar H, Conradi S, Delmotte MH, Lanteri-Minet M, Lefaucheur JP, Mick G, Piano V, Pickering G, Piquet E, Regis C, Salvat E, Attal N. Pharmacological and non-pharmacological treatments for neuropathic pain: Systematic review and French recommendations. Rev Neurol (Paris). 2020 May;176(5):325-352. doi: 10.1016/j.neurol.2020.01.361. Epub 2020 Apr 7.
PubMed 32276788Marineo G. Inside the Scrambler Therapy, a Noninvasive Treatment of Chronic Neuropathic and Cancer Pain: From the Gate Control Theory to the Active Principle of Information. Integr Cancer Ther. 2019 Jan-Dec;18:1534735419845143. doi: 10.1177/1534735419845143.
PubMed 31014125Majithia N, Smith TJ, Coyne PJ, Abdi S, Pachman DR, Lachance D, Shelerud R, Cheville A, Basford JR, Farley D, O'Neill C, Ruddy KJ, Sparadeo F, Beutler A, Loprinzi CL. Scrambler Therapy for the management of chronic pain. Support Care Cancer. 2016 Jun;24(6):2807-14. doi: 10.1007/s00520-016-3177-3. Epub 2016 Apr 4.
PubMed 27041741Wang EJ, Limerick G, D'Souza RS, Lobner K, Williams KA, Cohen SP, Smith TJ. Safety of Scrambler Therapy: A Systematic Review of Complications and Adverse Effects. Pain Med. 2023 Mar 1;24(3):325-340. doi: 10.1093/pm/pnac137.
PubMed 36069623Staff NP, Grisold A, Grisold W, Windebank AJ. Chemotherapy-induced peripheral neuropathy: A current review. Ann Neurol. 2017 Jun;81(6):772-781. doi: 10.1002/ana.24951. Epub 2017 Jun 5.
PubMed 28486769
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-Blind, Sham-Controlled Study of Scrambler Therapy for Chemotherapy-Induced Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT07219472
- Acronym / sponsor ID
- CASE3Y25
- Conditions
- Chemotherapy-induced Peripheral Neuropathy, CIPN - Chemotherapy-Induced Peripheral Neuropathy
- Keywords
- Scrambler therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- VelaSano
- Study start
- 27 Mar 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 Oct 2025 (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.
This research study is for people who have a condition called chemotherapy-induced peripheral neuropathy (CIPN). This condition develops as a result of receiving medication(s) to treat cancer, particularly chemotherapy. CIPN is characterized by pain, numbness, tingling or burning sensations, typically in the hands and feet of people. These symptoms can lead to physical suffering, limited ability to perform daily activities, and low quality of life. One of the ways to treat CIPN is using a device called Scrambler Therapy. Scrambler Therapy was approved by the Food and Drug Administration (FDA) in 2009 as a treatment for CIPN. The treatment involves electrical signals passing through wires attached to parts of the body via adhesive tabs near where symptoms of CIPN are experienced. A standard treatment course consists of 10 daily sessions lasting about one hour each. The purpose of this study is to determine the effect of a 10-day course of Scrambler Therapy on symptoms of chemotherapy-induced peripheral neuropathy, day-to-day activities, overall quality of life, and use of pain medications. Participants will be randomly assigned to one of two groups. One group will receive Scrambler Therapy. The other group will not receive it. Participants will not know which group they were in until after treatment has completed. Participants in the group who did not receive Scrambler Therapy will have the opportunity to receive it after one month. Participants will be in this research study about 12 to 14 months.
Detailed description
Neuropathy is damage or disease affecting the somatosensory nervous system. It can result in pain, numbness and other feelings of tingling or burning on the skin. Neuropathic pain often does not go away for a long time, which can negatively impact quality of life. Even though neuropathic pain comes from the nervous system, it is often managed with medications.
In recent years, Scrambler Therapy (ST) has come up as a way to treat neuropathic pain that does not use medications. ST was approved by the FDA in 2009 to treat neuropathic pain. It works by replacing or overriding pain signals and rewires the way that people may perceive pain. It was originally designed to treat cancer pain. A standard course of ST consists of ten daily sessions over two consecutive weeks. Treatment may stop early if participants no longer report feeling neuropathic pain.
Previous research on the effects of ST for neuropathic pain have shown positive findings with very few participants reporting negative side effects of ST treatment. However, there are some limitations of ST, including the time and cost of the treatment, limited availability of ST, and the necessary skills needed to administer it.
ST is a promising solution to pain caused by CIPN. CIPN occurs in 30-40% of people treated with chemotherapy. CIPN can sometimes cause interruptions in cancer treatment and negatively impact quality of life. The amount of people with CIPN may also rise as more people with cancer live longer. Due to this, it is important to explore ST as a treatment for CIPN. This study aims to investigate the short-term and long-term impacts of ST as an alternative to medication treatments for CIPN.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scrambler Therapy | Experimental | Device: Scrambler Therapy |
| Sham Scrambler Therapy | Sham comparator | Other: Sham/No Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adults with CIPN-related pain for at least three months duration, and for which the participant wants intervention
- At least three months from the last dose of neurotoxic cancer-directed drug
- No plan (at the time of study enrollment) for additional neurotoxic cancer-directed therapies for at least five months after trial enrollment
- Pain rated ≥ four out of 10 in severity (0-10 pain scale) during the seven days prior to enrollment
- > Six-month life expectancy
Key exclusion criteria (9 listed)
- Pregnant or nursing
- An operational implanted drug delivery system, implanted electronic medical device, life supporting medical device, and/or medical monitoring device
- History of myocardial infarction or ischemic heart disease within six months of trial enrollment
- History of epilepsy, brain damage resulting in seizure activity, or use of anticonvulsants for seizure
- Skin conditions such as open sores that will prevent proper application of electrodes
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 |
|---|---|---|
| Scrambler TherapyParticipants will attend 10 consecutive weekday 45-minute sessions of scrambler therapy. | Device | Scrambler Therapy |
| Sham/No InterventionParticipants will be blinded as to which arm they are in (experimental vs. sham comparator), and as such, participants in the sham comparator arm will attend 10 consecutive weekday 45-minute sessions of sham scrambler therapy. In the sham comparator arm, participants will NOT receive a therapeutic level of scrambler therapy. | Other | Sham Scrambler Therapy |
Primary outcome
Change in participant-reported pain
Time frame: Baseline, end of treatment (up to 14 days)
Participant-reported pain is measured by the Severity of Neuropathic Symptoms, in which participants rank their pain on a scale of 0 (Not at All) to 10 (Severe). Higher scores indicate greater pain symptoms.
4 secondary outcomes
Change in participant-reported non-pain neuropathic symptoms
Time frame: Baseline, end of treatment (up to 14 days)
Change in functional status
Time frame: Baseline, end of treatment (up to 14 days)
Change in quality of life
Time frame: Baseline, end of treatment (up to 14 days)
Change in participant-perceived treatment efficacy
Time frame: Baseline, end of treatment (up to 14 days)
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 5 Aug 2026.
- Background: PubMed 32584191Finnerup NB, Kuner R, Jensen TS. Neuropathic Pain: From Mechanisms to Treatment. Physiol Rev. 2021 Jan 1;101(1):259-301. doi: 10.1152/physrev.00045.2019. Epub 2020 Jun 25.
- Background: PubMed 31871494Szok D, Tajti J, Nyari A, Vecsei L. Therapeutic Approaches for Peripheral and Central Neuropathic Pain. Behav Neurol. 2019 Nov 21;2019:8685954. doi: 10.1155/2019/8685954. eCollection 2019.
- Background: PubMed 32276788Moisset X, Bouhassira D, Avez Couturier J, Alchaar H, Conradi S, Delmotte MH, Lanteri-Minet M, Lefaucheur JP, Mick G, Piano V, Pickering G, Piquet E, Regis C, Salvat E, Attal N. Pharmacological and non-pharmacological treatments for neuropathic pain: Systematic review and French recommendations. Rev Neurol (Paris). 2020 May;176(5):325-352. doi: 10.1016/j.neurol.2020.01.361. Epub 2020 Apr 7.
- Background: PubMed 31014125Marineo G. Inside the Scrambler Therapy, a Noninvasive Treatment of Chronic Neuropathic and Cancer Pain: From the Gate Control Theory to the Active Principle of Information. Integr Cancer Ther. 2019 Jan-Dec;18:1534735419845143. doi: 10.1177/1534735419845143.
- Background: PubMed 27041741Majithia N, Smith TJ, Coyne PJ, Abdi S, Pachman DR, Lachance D, Shelerud R, Cheville A, Basford JR, Farley D, O'Neill C, Ruddy KJ, Sparadeo F, Beutler A, Loprinzi CL. Scrambler Therapy for the management of chronic pain. Support Care Cancer. 2016 Jun;24(6):2807-14. doi: 10.1007/s00520-016-3177-3. Epub 2016 Apr 4.
- Background: PubMed 36069623Wang EJ, Limerick G, D'Souza RS, Lobner K, Williams KA, Cohen SP, Smith TJ. Safety of Scrambler Therapy: A Systematic Review of Complications and Adverse Effects. Pain Med. 2023 Mar 1;24(3):325-340. doi: 10.1093/pm/pnac137.
- Background: PubMed 28486769Staff NP, Grisold A, Grisold W, Windebank AJ. Chemotherapy-induced peripheral neuropathy: A current review. Ann Neurol. 2017 Jun;81(6):772-781. doi: 10.1002/ana.24951. Epub 2017 Jun 5.
- Individual participant dataSharing planned: No
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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.
Laura Shoemaker, DO, MS, FAAHPM principal investigator
Case Comprehensive Cancer Center, Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scrambler Therapy in people with Chemotherapy-induced Peripheral Neuropathy and CIPN - Chemotherapy-Induced Peripheral Neuropathy, run by Case Comprehensive 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 9 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 5 Aug 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. 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?
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?
Contact Laura Shoemaker, DO, MS, FAAHPM ((216) 444-5193, shoemal@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in participant-reported pain (time frame: Baseline, end of treatment (up to 14 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07219472, which also lists 7 linked publications.
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 5 Aug 2026.