Using Scrambler Therapy with Duloxetine for Chemotherapy-Induced Peripheral Neuropathy
Scrambler Therapy With Duloxetine-based Usual Care vs Duloxetine-based Usual Care for Chemotherapy-induced Peripheral Neuropathy: A Randomized Phase II Pilot Trial.
This study is testing if combining Scrambler therapy with duloxetine can help reduce pain in people who have chemotherapy-induced nerve damage.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fox Chase Cancer Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT06914557 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of Scrambler therapy combined with duloxetine compared to duloxetine alone in treating chemotherapy-induced peripheral neuropathy (CIPN). The study aims to determine if this combination can achieve a significant reduction in pain scores after 35 days of treatment. Participants will be assessed using various pain and function measurement tools, including the Brief Pain Inventory-Short Form and the EORTC CIPN-20. The trial focuses on patients who have experienced neuropathy as a side effect of chemotherapy and are currently on duloxetine.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with cancer who have experienced significant pain from CIPN and are currently on duloxetine.
Not a fit: Patients who are children, pregnant, or have certain medical devices or conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more effective treatment option for patients suffering from CIPN, potentially improving their quality of life.
How similar studies have performed: While duloxetine is a standard treatment for CIPN, the combination with Scrambler therapy is a novel approach that has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Philadelphia, Pennsylvania
- Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Marcin Chwistek, MD — Fox Chase Cancer Center
- Study coordinator: Gerald Nkogbu, MBBS, MS
- Email: gerald.nkogbu@fccc.edu
- Phone: 2157285378
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.