RECRUITING

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

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Conditions

Chemotherapy-Induced Peripheral NeuropathyHematopoietic and Lymphoid Cell NeoplasmMalignant Solid Neoplasm

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Optimizing Neurofeedback to Treat Chemotherapy Induced Peripheral Neuropathy

Quick Facts

Study Start:2020-07-10
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04560673

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients must have the ability to understand and read English, sign a written informed consent, and be willing to follow protocol requirements
  2. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  3. * 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
  4. * Neuropathic symptoms must be related to chemotherapy (in the opinion of the treating physician)
  5. * Patients must have had neuropathic symptoms for a minimum of 3 months
  6. * No plans to change pain medication regimen during the course of the study
  7. * Off active chemotherapy treatment for minimum of 3 months
  8. * 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
  9. * 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
  10. * 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
  11. * If participants agree to the Remote Training Option, participants should be willing to download necessary software to their home computer
  12. * 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
  1. * Patients who are taking any antipsychotic medications
  2. * Patients with active central nervous system (CNS) disease, such as clinically-evident metastases or leptomeningeal disease, dementia, or encephalopathy
  3. * Patients who have ever been diagnosed with bipolar disorder or schizophrenia
  4. * Patients with known, previously diagnosed peripheral neuropathy from causes other than chemotherapy
  5. * Patients who have a history of head injury or who have known seizure activity
  6. * Patients for whom any contraindications of DL are known
  7. * Patients with suicidal ideation
  8. * Patients who are already taking duloxetine for peripheral neuropathy

Contacts and Locations

Study Contact

Sarah Prinsloo
CONTACT
713-563-9627
sprinsloo@mdanderson.org

Principal Investigator

Sarah Prinsloo
PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center

Study Locations (Sites)

Harris Health System (LBJ)
Houston, Texas, 77026
United States
M D Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-07-10
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2020-07-10
Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

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