RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Scrambler Therapy With Duloxetine-based Usual Care vs Duloxetine-based Usual Care for Chemotherapy-induced Peripheral Neuropathy: A Randomized Phase II Pilot Trial.

Quick Facts

Study Start:2025-03-03
Study Completion:2027-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06914557

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Persons aged 18 years or older with cancer
  2. 2. Eastern Cooperative Oncology Group 0-2
  3. 3. At least a 4/10 average pain score prior to treatment
  4. 4. At least CTCAE version 5.0 grade 2 neuropathies.
  5. 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. 6. Score of at least 4 on the Douleur-Neuropathique-en-4 Questions (DN4) questionnaire
  7. 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. 8. Patients must be on duloxetine at least 30 mg po daily for at least 4 weeks prior to study initiation
  9. 9. Patients must be able to provide informed written consent.
  1. 1. Children or adolescents
  2. 2. Pregnant or nursing patients
  3. 3. Presence of an implantable life supporting medical device or implantable drug delivery system
  4. 4. Patients with severe skin conditions preventing the proper application of electrodes
  5. 5. Patients currently on monoamine oxidase inhibitors MAOIs.
  6. 6. Patients currently receiving gabapentin who are unable to be weaned off for other medical reasons (ST requires tapering gabapentin).
  7. 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. 8. Patients with leptomeningeal carcinomatosis- treated/stable brain metastases are allowed
  9. 9. Patients with severe depression, suicidal ideation, bipolar disease, alcohol abuse, a major eating disorder
  10. 10. Patients with uncontrolled epilepsy.
  11. 11. Patients who have previously attempted or undergone Scrambler therapy.

Contacts and Locations

Study Contact

Gerald Nkogbu, MBBS, MS
CONTACT
2157285378
gerald.nkogbu@fccc.edu
Leslie Fortin, MPH
CONTACT
215-214-3996
leslie.fortin@fccc.edu

Principal Investigator

Marcin Chwistek, MD
PRINCIPAL_INVESTIGATOR
Fox Chase Cancer Center

Study Locations (Sites)

Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19123
United States

Collaborators and Investigators

Sponsor: Fox Chase Cancer Center

  • Marcin Chwistek, MD, PRINCIPAL_INVESTIGATOR, Fox Chase Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-03
Study Completion Date2027-06-30

Study Record Updates

Study Start Date2025-03-03
Study Completion Date2027-06-30

Terms related to this study

Keywords Provided by Researchers

  • CIPN
  • neuropathy
  • Chemotherapy-Induced Peripheral Neuropathy
  • Duloxetine
  • Scrambler Therapy

Additional Relevant MeSH Terms

  • CIPN - Chemotherapy-Induced Peripheral Neuropathy
  • Pain