Summary

Eligibility
for people ages 25 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

Summary

This phase II/III trial studies the best dose of duloxetine and how well it works in preventing pain, tingling, and numbness (peripheral neuropathy) caused by treatment with oxaliplatin in patients with stage II-III colorectal cancer. Duloxetine increases the amount of certain chemicals in the brain that help relieve depression and pain. Giving duloxetine in patients undergoing treatment with oxaliplatin for colorectal cancer may help prevent peripheral neuropathy.

Official Title

Duloxetine to Prevent Oxaliplatin-Induced Chemotherapy-Induced Peripheral Neuropathy: a Randomized, Double-Blind, Placebo-Controlled Phase II to Phase III Study

Details

Keywords

Stage II Colorectal Cancer AJCC V8, Stage III Colorectal Cancer AJCC V8, Colorectal Neoplasms, Peripheral Nervous System Diseases, Oxaliplatin, Duloxetine Hydrochloride, Duloxetine, Quality-of-Life Assessment

Eligibility

Locations

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Alliance for Clinical Trials in Oncology
ID
NCT04137107
Phase
Phase 2/3 research study
Study Type
Interventional
Participants
About 220 people participating
Last Updated