Brain training plus drug may ease chemo nerve damage
NCT ID NCT04560673
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tests whether combining neurofeedback (a brain-wave training therapy) with the drug duloxetine can better relieve nerve pain caused by chemotherapy than either treatment alone. About 336 cancer survivors with persistent nerve pain will be randomly assigned to one of three groups: duloxetine only, neurofeedback only, or both together. The goal is to see if the combination reduces pain unpleasantness and improves quality of life after five weeks of treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- duloxetine and neurofeedback training
- What this could lead to
- If it works, this could offer a new way to manage nerve pain from chemotherapy without relying solely on medication.
- What could go wrong
- This is a mid-stage trial with 336 participants, so results are not yet proven. The combination may not be more effective than duloxetine alone, and neurofeedback requires time and commitment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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336 people
The number who actually took part.
- Started
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Jul 2020
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Harris Health System (LBJ)
Houston, Texas, 77026, United States
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M D Anderson Cancer Center
Houston, Texas, 77030, United States
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Other studies related to the condition(s) this trial covers.
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