NCT06914557 Scrambler Therapy With Duloxetine-based Usual Care vs Duloxetine-based Usual Care for Chemotherapy-induced Peripheral Neuropathy.
| NCT ID | NCT06914557 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Fox Chase Cancer Center |
| Condition | CIPN - Chemotherapy-Induced Peripheral Neuropathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-03-03 |
| Primary Completion | 2027-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 50 participants in total. It began in 2025-03-03 with a primary completion date of 2027-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. Persons aged 18 years or older with cancer 2. Eastern Cooperative Oncology Group 0-2 3. At least a 4/10 average pain score prior to treatment 4. At least CTCAE version 5.0 grade 2 neuropathies. 5. Diagnosed CIPN based on chart review or oncologist diagnosis; will allow pre-existing diabetic neuropathy if symptoms are changing or worsening after chemotherapy. 6. Score of at least 4 on the Douleur-Neuropathique-en-4 Questions (DN4) questionnaire 7. 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. 8. Patients must be on duloxetine at least 30 mg po daily for at least 4 weeks prior to study initiation 9. Patients must be able to provide informed written consent. Exclusion Criteria: 1. Children or adolescents 2. Pregnant or nursing patients 3. Presence of an implantable life supporting medical device or implantable drug delivery system 4. Patients with severe skin conditions preventing the proper application of electrodes 5. Patients currently on monoamine oxidase inhibitors MAOIs. 6. Patients currently receiving gabapentin who are unable to be weaned off for other medical reasons (ST requires tapering gabapentin). 7. Patients with a symptomatic neuropathy from any type of nerve compression (e.g. carpal tunnel or tarsal tunnel, radiculopathy, spinal stenosis, or brachial plexopathy) 8. Patients with leptomeningeal carcinomatosis- treated/stable brain metastases are allowed 9. Patients with severe depression, suicidal ideation, bipolar disease, alcohol abuse, a major eating disorder 10. Patients with uncontrolled epilepsy. 11. Patients who have previously attempted or undergone Scrambler therapy.
Contact & Investigator
Marcin Chwistek, MD
PRINCIPAL INVESTIGATOR
Fox Chase Cancer Center
Frequently Asked Questions
Who can join the NCT06914557 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying CIPN - Chemotherapy-Induced Peripheral Neuropathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06914557 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06914557 currently recruiting?
Yes, NCT06914557 is actively recruiting participants. Contact the research team at gerald.nkogbu@fccc.edu for enrollment information.
Where is the NCT06914557 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT06914557 clinical trial?
NCT06914557 is sponsored by Fox Chase Cancer Center. The principal investigator is Marcin Chwistek, MD at Fox Chase Cancer Center. The trial plans to enroll 50 participants.