Duloxetine and Neurofeedback Training for the Treatment of Chemotherapy Induced Peripheral Neurop… (NCT04560673) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Duloxetine and Neurofeedback Training for the Treatment of Chemotherapy Induced Peripheral Neuropathy
United States336 participantsStarted 2020-07-10
Plain-language summary
This phase II trial investigates how well duloxetine and neurofeedback training work in treating patients with chemotherapy induced peripheral neuropathy. Duloxetine is a type of serotonin and norepinephrine reuptake inhibitor that increases the amount of certain chemicals in the brain that help relieve depression and peripheral neuropathy. Neurofeedback training is a type of therapy that uses an electroencephalograph (EEG) and a computer software program to measure brain wave activity and may help teach patients with peripheral neuropathy (nerve damage) how to change their own brain waves to lower their feelings of neuropathy and help improve their overall quality of life. Giving duloxetine and neurofeedback training may work better in treating peripheral neuropathy caused by chemotherapy compared to duloxetine or neurofeedback training alone.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must have the ability to understand and read English, sign a written informed consent, and be willing to follow protocol requirements
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Pain score \>= 4 on a 0-10 numeric pain scale and/or grade 1-4 neuropathic pain according to the National Cancer Institute's 4 point grading scale
* Neuropathic symptoms must be related to chemotherapy (in the opinion of the treating physician)
* Patients must have had neuropathic symptoms for a minimum of 3 months
* No plans to change pain medication regimen during the course of the study
* Off active chemotherapy treatment for minimum of 3 months
* Hormonal (e.g., tamoxifen or Arimidex, etc.) and targeted (Tarceva and Avastin, etc.) therapies allowed as long as they will be continued during the course of the study
* Willing to come to one of the participating cancer centers for the therapy sessions; or willing to participate in the therapy sessions at their homes and live within a 45 minute drive of the main campuses; or can participate in the therapy sessions from MD Anderson regional care centers
* If participants agree to the Remote Training Option, participants should be willing to receive equipment at their homes and to return the equipment to MDA in case of malfunction or completion of the study
* If participants agree to the Remote Training Option, participants should be willing to download necessary software to their home computer
*…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Pain Quality Assessment Scale (PQAS) unpleasantness score