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Compares treatment options for CIPN - Chemotherapy-Induced Peripheral Neuropathy
Official title Scrambler Therapy With Duloxetine-based Usual Care vs Duloxetine-based Usual Care for Chemotherapy-induced Peripheral Neuropathy.
ClinicalTrials.gov ID: NCT06914557
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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).
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.