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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFox Chase Cancer Center

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

Treatment groups

50 Participants
are divided into 2 treatment groups

Sponsors and collaborators