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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Duloxetine — DRUG
  Given PO
• Neurofeedback — BEHAVIORAL
  Receive neurofeedback training
• Quality-of-Life Assessment — OTHER
  Ancillary studies
• Questionnaire Administration — OTHER
  Ancillary studies

Study Details

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.

Key Dates

Start date

Jul 10, 2020

Status verified

Dec 2025

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

380 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• Experimental: Group I (neurofeedback training, duloxetine)
  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.
• Experimental: Group II (neurofeedback training)
  Patients receive neurofeedback training over 1 hour 3-5 times weekly for up to 5 weeks.
• Experimental: Group III (duloxetine)
  Patients receive duloxetine PO QD for 5 weeks in the absence of unacceptable toxicity.

Primary Outcome Measure

Change in Pain Quality Assessment Scale (PQAS) unpleasantness score [ Time Frame: Baseline 5 up to week 10 ]

Central Contacts

• Sarah Prinsloo
  713-563-9627
  [email protected]

Locations (2)

Find similar trials in Houston, TX

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