RECRUITINGPhase 2INTERVENTIONAL

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.

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Persons aged 18 years or older with cancer 2. Eastern Cooperative Oncology Group 0-2 3. At least a 4/10 average pain score prior to treatment 4. At least CTCAE version 5.0 grade 2 neuropathies. 5. Diagnosed CIPN based on chart review or oncologist diagnosis; will allow pre-existing diabetic neuropathy if symptoms are changing or worsening after chemotherapy. 6. Score of at least 4 on the Douleur-Neuropathique-en-4 Questions (DN4) questionnaire 7. 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. 8. Patients must be on duloxetine at least 30 mg po daily for at least 4 weeks prior to study initiation 9. Patients must be able to provide informed written consent. Who Should NOT Join This Trial: 1. Children or adolescents 2. Pregnant or nursing patients 3. Presence of an implantable life supporting medical device or implantable drug delivery system 4. Patients with severe skin conditions preventing the proper application of electrodes 5. Patients currently on monoamine oxidase inhibitors MAOIs. 6. Patients currently receiving gabapentin who are unable to be weaned off for other medical reasons (ST requires tapering gabapentin). 7. Patients with a symptomatic neuropathy from any type of nerve compression (e.g. carpal tunnel or tarsal tunnel, radiculopathy, spinal stenosis, or brachial plexopathy) 8. Patients with leptomeningeal carcinomatosis- treated/stable brain metastases are allowed 9. Patients with severe depression, suicidal ideation, bipolar disease, alcohol abuse, a major eating disorder 10. Patients with uncontrolled epilepsy. 11. Patients who have previously attempted or undergone Scrambler therapy. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Persons aged 18 years or older with cancer 2. Eastern Cooperative Oncology Group 0-2 3. At least a 4/10 average pain score prior to treatment 4. At least CTCAE version 5.0 grade 2 neuropathies. 5. Diagnosed CIPN based on chart review or oncologist diagnosis; will allow pre-existing diabetic neuropathy if symptoms are changing or worsening after chemotherapy. 6. Score of at least 4 on the Douleur-Neuropathique-en-4 Questions (DN4) questionnaire 7. 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. 8. Patients must be on duloxetine at least 30 mg po daily for at least 4 weeks prior to study initiation 9. Patients must be able to provide informed written consent. Exclusion Criteria: 1. Children or adolescents 2. Pregnant or nursing patients 3. Presence of an implantable life supporting medical device or implantable drug delivery system 4. Patients with severe skin conditions preventing the proper application of electrodes 5. Patients currently on monoamine oxidase inhibitors MAOIs. 6. Patients currently receiving gabapentin who are unable to be weaned off for other medical reasons (ST requires tapering gabapentin). 7. Patients with a symptomatic neuropathy from any type of nerve compression (e.g. carpal tunnel or tarsal tunnel, radiculopathy, spinal stenosis, or brachial plexopathy) 8. Patients with leptomeningeal carcinomatosis- treated/stable brain metastases are allowed 9. Patients with severe depression, suicidal ideation, bipolar disease, alcohol abuse, a major eating disorder 10. Patients with uncontrolled epilepsy. 11. Patients who have previously attempted or undergone Scrambler therapy.

Treatments Being Tested

DEVICE

Scrambler 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.

OTHER

Questionnaire and Physical Exam

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

Locations (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States