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

• Status: Recruiting
• Trial end date: 2022-10-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Duloxetine Hydrochloride

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 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

• If participants agree to the Remote Training Option, participants should be willing to allow research staff remote access to their computer to run the neurofeedback program

Exclusion Criteria:

• Patients who are taking any antipsychotic medications

• Patients with active central nervous system (CNS) disease, such as clinically-evident metastases or leptomeningeal disease, dementia, or encephalopathy

• Patients who have ever been diagnosed with bipolar disorder or schizophrenia

• Patients with known, previously diagnosed peripheral neuropathy from causes other than chemotherapy

• Patients who have a history of head injury or who have known seizure activity

• Patients for whom any contraindications of DL are known

• Patients with suicidal ideation

• Patients who are already taking duloxetine for peripheral neuropathy