NCT06914557 · Fox Chase Cancer Center
Scrambler Therapy With Duloxetine-based Usual Care vs Duloxetine-based Usual Care for Chemotherapy-induced Peripheral Neuropathy.
What this study is about
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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
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).
Time frame: At Day 35
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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.
Where
- Philadelphia, Pennsylvania
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 9, 2025 · Source of record for eligibility and locations