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Scrambler Therapy with Duloxetine-Based Usual Care vs. Duloxetine-Based Usual Care for Chemotherapy-Induced Peripheral Neuropathy

ClinicalTrials.gov ID: NCT06914557
Protocol: 23-1043
Phase: II
Investigator: Marcin Chwistek, MD, FAAHPM
Disease(s): CIPN

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.

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

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.

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