Actively Recruiting
Scrambler Therapy With Duloxetine-based Usual Care vs Duloxetine-based Usual Care for Chemotherapy-induced Peripheral Neuropathy.
Led by Fox Chase Cancer Center · Updated on 2025-04-09
50
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Scrambler Therapy With Duloxetine-based Usual Care vs Duloxetine-based Usual Care for Chemotherapy-induced Peripheral Neuropathy.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older with cancer
- Eastern Cooperative Oncology Group performance status 0-2
- Average pain score of at least 4 out of 10 before treatment
- At least grade 2 neuropathy according to CTCAE version 5.0
- Diagnosed chemotherapy-induced peripheral neuropathy (CIPN); pre-existing diabetic neuropathy allowed if symptoms worsen after chemotherapy
- Score of at least 4 on the Douleur-Neuropathique-en-4 Questions (DN4) questionnaire
- Discontinued neurotoxic chemotherapy within the past 3 months with no planned therapy for 6 months after starting CIPN treatment
- Taking duloxetine at a minimum of 30 mg daily for at least 4 weeks before starting the study
- Able to give informed written consent
You will not qualify if you...
- Children or adolescents
- Pregnant or nursing patients
- Having implantable life-supporting medical devices or drug delivery systems
- Severe skin conditions preventing proper electrode placement
- Currently taking monoamine oxidase inhibitors (MAOIs)
- Receiving gabapentin and unable to taper off for medical reasons
- Neuropathy caused by nerve compression conditions (e.g., carpal tunnel, spinal stenosis)
- Leptomeningeal carcinomatosis (brain metastases allowed if treated and stable)
- Severe depression, suicidal thoughts, bipolar disorder, alcohol abuse, or major eating disorders
- Uncontrolled epilepsy
- Previous treatment with Scrambler therapy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19123
Actively Recruiting
Research Team
G
Gerald Nkogbu, MBBS, MS
CONTACT
L
Leslie Fortin, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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