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Brain training plus drug may ease chemo nerve damage

NCT ID NCT04560673

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

336 people

The number who actually took part.

Started

Jul 2020

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Harris Health System (LBJ)

    Houston, Texas, 77026, United States

  • M D Anderson Cancer Center

    Houston, Texas, 77030, United States

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