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

M.D. Anderson Cancer Center

Status and phase: Enrolling; Phase 2

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

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04560673

NCI-2020-06553 (Registry Identifier)

2019-0712 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 380 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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380 participants in 3 patient groups

Group I (neurofeedback training, duloxetine)

Experimental group

Description:

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.

Treatment:

Drug: Duloxetine

Other: Quality-of-Life Assessment

Behavioral: Neurofeedback

Other: Questionnaire Administration

Group II (neurofeedback training)

Experimental group

Description:

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

Treatment:

Other: Quality-of-Life Assessment

Behavioral: Neurofeedback

Other: Questionnaire Administration

Group III (duloxetine)

Experimental group

Description:

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

Treatment:

Drug: Duloxetine

Other: Quality-of-Life Assessment

Other: Questionnaire Administration