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

Recruiting now · Phase 2

Conditions studied: CIPN - Chemotherapy-Induced Peripheral Neuropathy, Pain

In brief

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.

Key facts

Study ID

NCT06914557

Run by

Fox Chase Cancer Center

People needed

50

Starts

2025-03-03

Expected to finish

2027-06-30

Last updated by the study team

2025-04-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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