Scrambler Therapy for Chemotherapy-Induced Peripheral Neuropathy

NCT ID: NCT07219472

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-28
• Study Completion Date: 2027-12-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Scrambler Therapy

Group Type: EXPERIMENTAL

Scrambler Therapy

Intervention Type: DEVICE

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

Sham Scrambler Therapy

Group Type: SHAM_COMPARATOR

Sham/No Intervention

Intervention Type: 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.

Interventions

Scrambler Therapy

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

Intervention Type: DEVICE

Sham/No Intervention

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VelaSano

UNKNOWN

Sponsor Role: collaborator

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laura Shoemaker, DO, MS, FAAHPM

Role: PRINCIPAL_INVESTIGATOR

Case Comprehensive Cancer Center, Cleveland Clinic

Locations

Case Comprehensive Cancer Center, Cleveland Clinic Foundation Taussig Cancer Institute

Cleveland, Ohio, United States

Countries

United States

Central Contacts

Laura Shoemaker, DO, MS, FAAHPM

Role: CONTACT

shoemal@ccf.org

(216) 444-5193

Facility Contacts

Laura Shoemaker, DO, MS, FAAHPM

Role: primary

shoemal@ccf.org

(216) 444-5193

References

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.

Reference Type: BACKGROUND

PMID: 32584191 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31871494 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32276788 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31014125 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27041741 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36069623 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28486769 (View on PubMed)

Other Identifiers

CASE3Y25

Identifier Type: -

Identifier Source: org_study_id