RecruitingPhase 2NCT06914557

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

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

Sponsor

Fox Chase Cancer Center

Enrollment

50 participants

Start Date

Mar 3, 2025

Study Type

INTERVENTIONAL

Conditions

Pain CIPN - Chemotherapy-Induced Peripheral Neuropathy

Summary

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

Min Age: 18 Years

Inclusion Criteria9

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.

Exclusion Criteria11

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
Patients currently on monoamine oxidase inhibitors MAOIs.
Patients currently receiving gabapentin who are unable to be weaned off for other medical reasons (ST requires tapering gabapentin).
Patients with a symptomatic neuropathy from any type of nerve compression (e.g. carpal tunnel or tarsal tunnel, radiculopathy, spinal stenosis, or brachial plexopathy)
Patients with leptomeningeal carcinomatosis- treated/stable brain metastases are allowed
Patients with severe depression, suicidal ideation, bipolar disease, alcohol abuse, a major eating disorder
Patients with uncontrolled epilepsy.
Patients who have previously attempted or undergone Scrambler therapy.

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Interventions

DEVICEScrambler Therapy

Scrambler 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.

OTHERQuestionnaire and Physical Exam

15-minute-long questionnaires evaluating Pain and degree of pain.