Scrambler Therapy With Duloxetine-based Usual Care vs Duloxetine-based Usual Care for Chemotherapy-induced Peripheral Neuropathy: A Randomized Phase II Pilot Trial.
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.
• Persons aged 18 years or older with cancer
• Eastern Cooperative Oncology Group 0-2
• At least a 4/10 average pain score prior to treatment
• At least CTCAE version 5.0 grade 2 neuropathies.
• Diagnosed CIPN based on chart review or oncologist diagnosis; will allow pre-existing diabetic neuropathy if symptoms are changing or worsening after chemotherapy.
• Score of at least 4 on the Douleur-Neuropathique-en-4 Questions (DN4) questionnaire
• 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.
• Patients must be on duloxetine at least 30 mg po daily for at least 4 weeks prior to study initiation
• Patients must be able to provide informed written consent.