Overview

Efficacy and Safety of Duloxetine in Chinese Solid Tumor Patients With Taxanes-induced Painful Peripheral Neuropathy

Status:
Recruiting
Trial end date:
2024-01-01
Target enrollment:
Participant gender:
Summary
The study is to evaluate the efficacy and safety of duloxetine in Chinese solid tumor patients with taxanes-induced painful peripheral neuropathy. Duloxetine will be given to patients who have grade 1 or higher sensory neuropathy according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and at least 4 on a scale of 0 to 10 points, representing average chemotherapy-induced pain, after taxanes treatment. Patient-reported pain severity, functional interference, emotion condition and quality of Life will be assessed weekly using corresponding scales. Blood samples will be collected from each enrolled subjects before the start of treatment, and the potential biomarkers in predicting duloxetine efficacy or safety will be explored by genomic profiling.
Phase:
Phase 2
Details
Lead Sponsor:
Yan Yang, MD, Ph.D
Treatments:
Duloxetine Hydrochloride