Clinical trial NCT04560673: Duloxetine and Neurofeedback Training for the Treatment of Chemotherapy Induced Peripheral Neuropathy
Official title: Optimizing Neurofeedback to Treat Chemotherapy Induced Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Chemotherapy-Induced Peripheral Neuropathy
Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-09-23
Enrollment: 380
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: PRIMARY OBJECTIVE:

I. 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:

I. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Pain Quality Assessment Scale (PQAS) unpleasantness score
timeFrame: Baseline 5 up to week 10
Secondary outcomes:
measure: Change in PQAS unpleasantness score
timeFrame: Baseline 5 up to week 10
measure: Baseline brain signatures as predictors of response to NFB and to DL
timeFrame: Up to week 5
measure: Evaluation of patients who will require more sessions of NFB to achieve relief of symptoms
timeFrame: Up to 12 months post-treatment
measure: Change in cancer-related symptoms
timeFrame: Baseline up to 12 months post-treatment
measure: Change in physical functioning
timeFrame: Baseline up to 12 months post-treatment
measure: Change in quality of life
timeFrame: Baseline up to 12 months post-treatment
Other outcomes:
Locations:
city: Houston
country: United States
facility: Harris Health System (LBJ)
state: Texas
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Sarah Prinsloo
role: PRINCIPAL_INVESTIGATOR
References: