NCT04560673

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

Optimizing Neurofeedback to Treat Chemotherapy Induced Peripheral Neuropathy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 380 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Duloxetine	Given PO
BEHAVIORAL	Neurofeedback	Receive neurofeedback training
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2020-07-10
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2020-09-23
• Last updated: 2025-12-31

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study