Actively Recruiting
Duloxetine and Neurofeedback Training for the Treatment of Chemotherapy Induced Peripheral Neuropathy
Led by M.D. Anderson Cancer Center · Updated on 2025-12-31
380
Participants Needed
2
Research Sites
337 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Duloxetine and Neurofeedback Training for the Treatment of Chemotherapy Induced Peripheral Neuropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and read English, sign informed consent, and follow study requirements
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Pain score of 4 or higher on a 0-10 scale and/or grade 1-4 neuropathic pain
- Neuropathic symptoms related to chemotherapy as determined by physician
- Neuropathic symptoms present for at least 3 months
- No plans to change pain medication during the study
- Off active chemotherapy for at least 3 months
- Hormonal and targeted therapies allowed if continued during study
- Willingness to attend therapy sessions at participating centers, at home within 45 minutes of main campuses, or at regional care centers
- Willingness to participate in remote training, including receiving and returning equipment, downloading software, and allowing remote research access if applicable
You will not qualify if you...
- Taking any antipsychotic medications
- Active central nervous system disease such as metastases, leptomeningeal disease, dementia, or encephalopathy
- History of bipolar disorder or schizophrenia
- Known peripheral neuropathy from causes other than chemotherapy
- History of head injury or known seizure activity
- Known contraindications to duloxetine
- Suicidal ideation
- Currently taking duloxetine for peripheral neuropathy
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Harris Health System (LBJ)
Houston, Texas, United States, 77026
Actively Recruiting
2
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
S
Sarah Prinsloo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
3
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