Scrambler Therapy for Chemotherapy-Induced Peripheral Neuropathy

NCT07219472 | Recruiting DMC FDA Device

• 1 other identifier: CASE3Y25
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chemotherapy-induced Peripheral Neuropathy; CIPN - Chemotherapy-Induced Peripheral Neuropathy

Keywords

Scrambler therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, end of treatment (up to 14 days)

Secondary Outcomes (4)

• Change in participant-reported non-pain neuropathic symptoms

  Baseline, end of treatment (up to 14 days)

• Change in functional status

  Baseline, end of treatment (up to 14 days)

• Change in quality of life

  Baseline, end of treatment (up to 14 days)

• Change in participant-perceived treatment efficacy

  Baseline, end of treatment (up to 14 days)

Other Outcomes (1)

• Change in participant-reported analgesic use for CIPN

  Baseline, end of treatment (up to 14 days)

Study Arms (2)

Scrambler Therapy

EXPERIMENTAL

Device: Scrambler Therapy

Sham Scrambler Therapy

SHAM COMPARATOR

Other: Sham/No Intervention

Interventions

Scrambler Therapy DEVICE

Participants will attend 10 consecutive weekday 45-minute sessions of scrambler therapy.

Scrambler Therapy

Sham/No Intervention OTHER

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.

Sham Scrambler Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Able to provide informed written consent
• ECOG Performance Status score ≥ two

You may not qualify if:

• 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
• History of symptomatic peripheral neuropathy prior to receiving neurotoxic chemotherapy
• Prior treatment with Scrambler Therapy

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• VelaSano: collaborator

Study Sites (1)

Case Comprehensive Cancer Center, Cleveland Clinic Foundation Taussig Cancer Institute

Cleveland, Ohio, 44195, United States

RECRUITING

Related Publications (7)

• 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.

  PMID: 32584191 BACKGROUND

• Szok 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.

  PMID: 31871494 BACKGROUND

• Moisset 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.

  PMID: 32276788 BACKGROUND

• Marineo 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.

  PMID: 31014125 BACKGROUND

• Majithia 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.

  PMID: 27041741 BACKGROUND

• Wang 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.

  PMID: 36069623 BACKGROUND

• Staff 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.

  PMID: 28486769 BACKGROUND

Study Officials

• Laura Shoemaker, DO, MS, FAAHPM

  Case Comprehensive Cancer Center, Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Shoemaker, DO, MS, FAAHPM

CONTACT

(216) 444-5193; shoemal@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2025
• First Posted: October 21, 2025
• Study Start: March 27, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)