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Duloxetine and Neurofeedback for Chemotherapy-Induced Neuropathy

This study is looking at how well duloxetine and neurofeedback training work together to treat chemotherapy-induced peripheral neuropathy (nerve damage caused by chemotherapy). Duloxetine is a medication that helps relieve pain by affecting certain brain chemicals. Neurofeedback training uses a machine to measure your brain waves and help you learn to control them to reduce neuropathy symptoms. You might be able to join if you are 18 or older, can read English, and have a pain score of 4 or higher from your neuropathy. The researchers will measure changes in your pain unpleasantness score to see if the treatments are successful. The study is currently recruiting 336 participants.

Study design
This is an interventional study where 336 participants will be randomly assigned to one of three groups to receive duloxetine, neurofeedback, or both.
What's involved
You would receive either duloxetine by mouth daily, neurofeedback training 3-5 times weekly for up to 5 weeks, or both. Ancillary studies like quality-of-life assessments and questionnaires will also be administered.
Compensation
Not stated in the trial record.
Follow-up
After completing the study treatment, participants will be followed up at 6 and 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04560673

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

Active, Not Recruiting
PHASE2Ages 18+InterventionalSupportive care
M.D. Anderson Cancer Center
~336 participants
Updated 2026-06-24 on ClinicalTrials.gov
What's tested:DuloxetineNeurofeedbackQuality-of-Life AssessmentQuestionnaire Administration

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Pain Quality Assessment Scale (PQAS) unpleasantness score
Measured over Baseline 5 up to week 10

Conditions

Chemotherapy-Induced Peripheral Neuropathy
Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm

Explore related trials

Chemotherapy-Induced Peripheral NeuropathyHematopoietic and Lymphoid Cell NeoplasmMalignant Solid Neoplasm

Where it's being run

2 sites across 1 states
Texas2

Study leadership

  • Sarah Prinsloo · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in Pain Quality Assessment Scale (PQAS) unpleasantness scoreBaseline 5 up to week 10

    The primary analysis will be a linear model comparing the mean difference in the change of the unpleasantness subscale of the (PQAS)Pain Quality Assessment Scale from baseline to the end of treatment (5 weeks) between the combination arm, the duloxetine (DL), and the neurofeedback (NFB) arm while adjusting for the stratification factor. Pain Quality Assessment Scale (0-10) 0-No pain-10 Most Intense Pain Imaginable.