Scrambler Therapy With Duloxetine-based Usual Care vs Duloxetine-based Usual Care for Chemotherapy-induced Peripheral Neuropathy.

NCT06914557 | Recruiting Phase 2 FDA Device

• 1 other identifier: 23-1043
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators hypothesize that Scrambler therapy with duloxetine, compared to duloxetine-based usual care, will result in greater improvement in CIPN as measured by the BPI-Short Form. In addition, the investigators will further assess pain using the EORTC CIPN-20 and determine whether Scrambler therapy results in improved levels of function as measured with the PDQ, and a decreased need for opioid medications. Our primary objective is to investigate whether Scrambler therapy with duloxetine is superior to duloxetine-based usual care in achieving at least a 50% reduction in pain scores, when comparing the cross-sectionally measured "average" pain score at day 35 to the cross-sectionally measured "average" pain score at baseline.

Conditions

CIPN - Chemotherapy-Induced Peripheral Neuropathy; Pain

Keywords

CIPN; neuropathy; Chemotherapy-Induced Peripheral Neuropathy; Duloxetine; Scrambler Therapy

Outcome Measures

Primary Outcomes (1)

• The difference in the proportion with a 50% reduction in pain scores when comparing the cross-sectionally measured "average" pain score at day 35 with the cross-sectionally measured "average" pain score at baseline (baseline = day 1).

  Investigate whether Scrambler therapy with duloxetine is superior to duloxetine alone in patient achievement of at least a 50% reduction in pain scores when comparing the cross-sectionally measured "average" pain score at day 35 to the cross-sectionally measured "average" pain score at baseline (baseline = day 1).

  At Day 35

Secondary Outcomes (1)

• Proportion of patients achieving ≥30% reduction in average pain score on BPI from baseline to day 35 and day 56: secondary analysis including wait-list control post-crossover outcomes.

  At Day 35 & Day 56

Study Arms (2)

Duloxetine Group

OTHER

Patients will be treated with Duloxetine as per Specialized Outpatient Palliative Care SOPC standard neuropathy treatment protocol

Other: Questionnaire and Physical Exam

Scrambler + Duloxetine

ACTIVE COMPARATOR

Patients' pharmacological treatment of their CIPN (including the management of duloxetine and other co-analgesics) will follow SOPC standard neuropathy treatment protocol

Device: Scrambler Therapy; Other: Questionnaire and Physical Exam

Interventions

Scrambler Therapy DEVICE

Scrambler therapy will be administered by the staff of the Supportive Oncology and Palliative Care team who have been trained in Scrambler therapy and have extensive experience providing it to patients with neuropathic cancer-related pain. Patients who meet the study criteria will be treated daily, Monday through Friday, for up to 10 sessions. The treatment may be terminated sooner if a patient experiences complete pain relief or if it is ineffective after five sessions. Patients will be closely monitored during the treatment. The treatment is non-painful and not associated with any significant adverse effects.

Also known as: Scrambler device therapy

Scrambler + Duloxetine

Questionnaire and Physical Exam OTHER

15-minute-long questionnaires evaluating Pain and degree of pain.

Also known as: EORTC QLQ-CIPN20, PDQ

Duloxetine Group; Scrambler + Duloxetine

Eligibility Criteria

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

You may qualify if:

• Persons aged 18 years or older with cancer
• Eastern Cooperative Oncology Group 0-2
• At least a 4/10 average pain score prior to treatment
• At least CTCAE version 5.0 grade 2 neuropathies.
• Diagnosed CIPN based on chart review or oncologist diagnosis; will allow pre-existing diabetic neuropathy if symptoms are changing or worsening after chemotherapy.
• Score of at least 4 on the Douleur-Neuropathique-en-4 Questions (DN4) questionnaire
• Patients must have discontinued neurotoxic chemotherapy within the last 3 months with no additional therapy planned for the next 6 months after initiation of CIPN treatment.
• Patients must be on duloxetine at least 30 mg po daily for at least 4 weeks prior to study initiation
• Patients must be able to provide informed written consent.

You may not qualify if:

• Children or adolescents
• Pregnant or nursing patients
• Presence of an implantable life supporting medical device or implantable drug delivery system
• Patients with severe skin conditions preventing the proper application of electrodes
• Patients currently on monoamine oxidase inhibitors MAOIs.
• Patients currently receiving gabapentin who are unable to be weaned off for other medical reasons (ST requires tapering gabapentin).
• Patients with a symptomatic neuropathy from any type of nerve compression (e.g. carpal tunnel or tarsal tunnel, radiculopathy, spinal stenosis, or brachial plexopathy)
• Patients with leptomeningeal carcinomatosis- treated/stable brain metastases are allowed
• Patients with severe depression, suicidal ideation, bipolar disease, alcohol abuse, a major eating disorder
• Patients with uncontrolled epilepsy.
• Patients who have previously attempted or undergone Scrambler therapy.

Sponsors & Collaborators

• Fox Chase Cancer Center: lead

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19123, United States

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Surveys and Questionnaires; Restraint, Physical

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Behavior Control; Therapeutics; Immobilization

Study Officials

• Marcin Chwistek, MD

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gerald Nkogbu, MBBS, MS

CONTACT

2157285378; gerald.nkogbu@fccc.edu

Leslie Fortin, MPH

CONTACT

215-214-3996; leslie.fortin@fccc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR/MD

Model Details: The investigators propose a randomized wait-list control study comparing the effectiveness of Scrambler therapy with duloxetine to duloxetine-based usual care, which is the current standard for CIPN treatment. Wait-list control studies allow the control group to cross over to the intervention arm after the control period. These studies are commonly used in behavioral trials to ensure all participants have access to a potentially beneficial intervention. Wait-list control designs may also enhance accrual if the intervention is perceived as desirable by participants.

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: April 6, 2025
• Study Start: March 3, 2025
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)