Status:
RECRUITING
Scrambler Therapy With Duloxetine-based Usual Care vs Duloxetine-based Usual Care for Chemotherapy-induced Peripheral Neuropathy.
Lead Sponsor:
Fox Chase Cancer Center
Conditions:
CIPN - Chemotherapy-Induced Peripheral Neuropathy
Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Detailed Description
Chemotherapy-induced peripheral neuropathy (CIPN) is a frequently experienced and often persistent side effect of many commonly utilized chemotherapy regimens. This list of agents includes platinum ag...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06914557
Start Date
March 3 2025
End Date
June 30 2027
Last Update
April 9 2025
Active Locations (1)
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1
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19123