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

NCT04560673 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: 2019-0712NCI-2020-06553
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 2

Brief 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 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

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

Outcome Measures

Primary Outcomes (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.

  Baseline 5 up to week 10

Secondary Outcomes (6)

• Change in PQAS unpleasantness score

  Baseline 5 up to week 10

• Baseline brain signatures as predictors of response to NFB and to DL

  Up to week 5

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

  Up to 12 months post-treatment

• Change in cancer-related symptoms

  Baseline up to 12 months post-treatment

• Change in physical functioning

  Baseline up to 12 months post-treatment

Study Arms (3)

Group I (neurofeedback training, duloxetine)

EXPERIMENTAL

Patients 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.

Drug: Duloxetine; Behavioral: Neurofeedback; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Group II (neurofeedback training)

EXPERIMENTAL

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

Behavioral: Neurofeedback; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Group III (duloxetine)

EXPERIMENTAL

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

Drug: Duloxetine; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Duloxetine DRUG

Given PO

Group I (neurofeedback training, duloxetine); Group III (duloxetine)

Neurofeedback BEHAVIORAL

Receive neurofeedback training

Also known as: EEG biofeedback

Group I (neurofeedback training, duloxetine); Group II (neurofeedback training)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Group I (neurofeedback training, duloxetine); Group II (neurofeedback training); Group III (duloxetine)

Questionnaire Administration OTHER

Ancillary studies

Group I (neurofeedback training, duloxetine); Group II (neurofeedback training); Group III (duloxetine)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Harris Health System (LBJ)

Houston, Texas, 77026, United States

RECRUITING

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Duloxetine Hydrochloride; Neurofeedback

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Biofeedback, Psychology; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Sarah Prinsloo

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Prinsloo

CONTACT

713-563-9627; sprinsloo@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2020
• First Posted: September 23, 2020
• Study Start: July 10, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

US (2)