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Chemotherapy-Induced Peripheral NeuropathyPhase 2NCT04560673

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

A Phase 2 study testing Duloxetine, Neurofeedback and Quality-of-Life Assessment in people with Chemotherapy-Induced Peripheral Neuropathy and Hematopoietic and Lymphoid Cell Neoplasm, run by M.D. Anderson Cancer Center at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Duloxetine, Neurofeedback and Quality-of-Life Assessment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
336 participants
Where
2 sitesUnited States
Study dates
10 Jul 2020to 31 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Harris Health System (LBJ)

    Houston, Texas, 77026

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Optimizing Neurofeedback to Treat Chemotherapy Induced Peripheral Neuropathy

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. Determine if the combination of duloxetine (DL) and neurofeedback (NFB) is superior to DL or NFB alone in treating chemotherapy induced peripheral neuropathy (CIPN).

SECONDARY OBJECTIVES:

  1. Determine the optimal number of neurofeedback sessions needed to result in long-term relief of CIPN in a large cohort of cancer survivors and across socioeconomic groups.

II. Examine baseline brain signatures as a predictor of response to neurofeedback (NFB) and to duloxetine and determine who will require more sessions of NFB to achieve relief of symptoms.

III. Examine if the combination of DL + NFB (than those getting DL or NFB alone) or a larger number of NFB sessions results in better improvements in cancer-related symptoms, physical functioning, and quality of life (QOL).

OUTLINE: Patients are randomized to 1 of 3 groups.

GROUP I: Patients receive neurofeedback training over 1 hour each 3-5 times weekly for up to 5 weeks. Patients also receive duloxetine orally (PO) once daily (QD) for 5 weeks in the absence of unacceptable toxicity.

GROUP II: Patients receive neurofeedback training session over 1 hour 3-5 times weekly for up to 5 weeks.

GROUP III: Patients receive duloxetine PO QD for 5 weeks in the absence of unacceptable toxicity.

After completion of study, patients are followed up at 6 and 12 months.

Being tested
Duloxetine, Neurofeedback, Quality-of-Life Assessment, Questionnaire Administration
Medical subject headings
Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DuloxetineDrug

    Given PO

  • NeurofeedbackBehavioural

    Also called EEG biofeedback

    Receive neurofeedback training

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT04560673
Study groupRoleWhat they receive
Group I (neurofeedback training, duloxetine)ExperimentalPatients receive neurofeedback training over 1 hour 3-5 times weekly for up to 5 weeks. Patients also receive duloxetine PO QD for 5 weeks in the absence of unacceptable toxicity.
Receives: Drug: Duloxetine; Behavioral: Neurofeedback; Other: Quality-of-Life Assessment; Other: Questionnaire Administration
Group II (neurofeedback training)ExperimentalPatients receive neurofeedback training over 1 hour 3-5 times weekly for up to 5 weeks.
Receives: Behavioral: Neurofeedback; Other: Quality-of-Life Assessment; Other: Questionnaire Administration
Group III (duloxetine)ExperimentalPatients receive duloxetine PO QD for 5 weeks in the absence of unacceptable toxicity.
Receives: Drug: Duloxetine; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Pain Quality Assessment Scale (PQAS) unpleasantness score

    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.

    Measured: Baseline 5 up to week 10

Secondary outcomes (6)

  1. Change in PQAS unpleasantness score

    Will use analysis of covariance (ANCOVA) to evaluate whether chemotherapy induced peripheral neuropathy (CIPN) differs across the three subgroups with 0, 10 or 15 additional sessions of NFB, among the participants from the NFB + DL group who report at least 1-point clinical improvement in CIPN at week 5. The analysis will adjust for the baseline outcome (at week 5), time with CIPN symptoms (minimization factor), and other covariates such as age, sex, cancer stage, time since diagnosis, and cancer type, as appropriate. Pain Quality Assessment Scale (0-10) 0-No pain-10 Most Intense Pain Imaginable.

    Measured: Baseline 5 up to week 10

  2. Baseline brain signatures as predictors of response to NFB and to DL

    Will perform ANCOVA with the change of the unpleasantness subscale from baseline to week 5 (i.e., end of the first 15 sessions of NFB) as the outcome, intervention (NFB, DL or combo), the brain signature (one at a time) and its interaction with intervention as the independent variables of interest. Pain Quality Assessment Scale (0-10) 0-No pain-10 Most Intense Pain Imaginable.

    Measured: Up to week 5

  3. Evaluation of patients who will require more sessions of NFB to achieve relief of symptoms

    Linear mixed model (LMM) analyses will be performed using data measured at end of treatment, months 6 and 12 only on patients who report clinical improvement at week 5.

    Measured: Up to 12 months post-treatment

  4. Change in cancer-related symptoms

    ANCOVA and LMM analyses will be performed to evaluate the effect of the number of additional NFB sessions on cancer-related symptoms.

    Measured: Baseline up to 12 months post-treatment

  5. Change in physical functioning

    ANCOVA and LMM analyses will be performed to evaluate the effect of the number of additional NFB sessions on physical functioning.

    Measured: Baseline up to 12 months post-treatment

  6. Change in quality of life

    ANCOVA and LMM analyses will be performed to evaluate the effect of the number of additional NFB sessions on quality of life.

    Measured: Baseline up to 12 months post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2020
  2. Study start10 Jul 2020
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
336 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04560673
Sponsor's protocol ID
2019-0712
Other IDs
NCI-2020-06553, 2019-0712
Status last verified
Jun 2026
First submitted
11 Sep 2020
Last updated
24 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Duloxetine, Neurofeedback and Quality-of-Life Assessment in people with Chemotherapy-Induced Peripheral Neuropathy and Hematopoietic and Lymphoid Cell Neoplasm, run by M.D. Anderson Cancer Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Pain Quality Assessment Scale (PQAS) unpleasantness score (time frame: Baseline 5 up to week 10). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04560673.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.

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