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RECRUITING
NCT04970121
PHASE2

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

Sponsor: Yan Yang, MD, Ph.D

View on ClinicalTrials.gov

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.

Official title: A Single-Center, Single-Arm Clinical Trail Evaluating Efficacy and Safety of Duloxetine in Chinese Solid Tumor Patients with Taxanes-induced Painful Peripheral Neuropathy

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2021-08-21

Completion Date

2025-12-01

Last Updated

2024-09-25

Healthy Volunteers

No

Interventions

DRUG

Duloxetine

Duloxetine, tablets, 20mg as starting dose and up to 60mg as maximum dose, once daily. Taxanes is used according to manual instruction and patient condition.

Locations (1)

Jing Liu

Bengbu, Anhui, China