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Recruiting Phase 2 NCT04560673

Duloxetine and Neurofeedback Training for the Treatment of Chemotherapy Induced Peripheral Neuropathy

Trial Parameters

Condition Chemotherapy-Induced Peripheral Neuropathy
Sponsor M.D. Anderson Cancer Center
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 380
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2020-07-10
Completion 2026-12-31
Interventions
DuloxetineNeurofeedbackQuality-of-Life Assessment

Brief 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.

Eligibility Criteria

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

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