RecruitingPhase 2NCT04560673

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

Optimizing Neurofeedback to Treat Chemotherapy Induced Peripheral Neuropathy


Sponsor

M.D. Anderson Cancer Center

Enrollment

380 participants

Start Date

Jul 10, 2020

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a combination of the drug duloxetine (an antidepressant also used for nerve pain) and neurofeedback training — a technique where patients learn to control their brain waves using real-time feedback — can reduce nerve pain caused by chemotherapy. **You may be eligible if...** - You have nerve pain (numbness, tingling, or pain in hands/feet) from chemotherapy that has lasted at least 3 months - Your pain score is 4 or higher on a 0-10 scale - You have finished chemotherapy at least 3 months ago - You are able to read and understand English - You can travel to a cancer center or participate remotely **You may NOT be eligible if...** - You plan to change your pain medications during the study - You are still receiving active chemotherapy - You live more than 45 minutes from a participating center and cannot participate remotely Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDuloxetine

Given PO

BEHAVIORALNeurofeedback

Receive neurofeedback training

OTHERQuality-of-Life Assessment

Ancillary studies

OTHERQuestionnaire Administration

Ancillary studies


Locations(2)

Harris Health System (LBJ)

Houston, Texas, United States

M D Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT04560673


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