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

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.

Conditions

CIPN - Chemotherapy-Induced Peripheral Neuropathy, Pain

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

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

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

Condition
CIPN - Chemotherapy-Induced Peripheral Neuropathy
Intervention / Treatment

-

Contacts and Locations

Philadelphia

Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States, 19123

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Fox Chase Cancer Center,

Marcin Chwistek, MD, PRINCIPAL_INVESTIGATOR, Fox Chase Cancer Center

Study Record Dates

2027-06-30