About this 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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Children or adolescents
Pregnant or nursing patients
Presence of an implantable life supporting medical device or implantable drug delivery system
Patients with severe skin conditions preventing the proper application of electrodes
Trial design
Treatments tested in this trial
- Scrambler Therapy
- Questionnaire and Physical Exam