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.
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
Crossover
Scrambler Therapy
DeviceScrambler therapy will be administered by the staff of the Supportive Oncology and Palliative Care team who have been trained in Scrambler therapy and have extensive experience providing it to patients with neuropathic cancer-related pain. Patients who meet the study criteria will be treated daily, Monday through Friday, for up to 10 sessions. The treatment may be terminated sooner if a patient experiences complete pain relief or if it is ineffective after five sessions. Patients will be closely monitored during the treatment. The treatment is non-painful and not associated with any significant adverse effects.
Questionnaire and Physical Exam
Other intervention15-minute-long questionnaires evaluating Pain and degree of pain.
The difference in the proportion with a 50% reduction in pain scores when comparing the cross-sectionally measured "average" pain score at day 35 with the cross-sectionally measured "average" pain score at baseline (baseline = day 1).
Investigate whether Scrambler therapy with duloxetine is superior to duloxetine alone in patient achievement of 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 (baseline = day 1).
Proportion of patients achieving ≥30% reduction in average pain score on BPI from baseline to day 35 and day 56: secondary analysis including wait-list control post-crossover outcomes.
Investigate the proportion of patients between arms who achieve at least 30% reduction in their cross-sectionally measured "average" pain score on the BPI from baseline (day 1) to day 35 and from day 1 to day 56. The wait-list control outcomes post-crossover will be included in this secondary analysis.
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