Sponsor: Alliance for Clinical Trials in Oncology
Sponsor Study ID: A221805
Study Title: Duloxetine to Prevent Oxaliplatin Induced Chemotherapy Induced Peripheral Neuropathy: A Randomized, Double Blind, Placebo Controlled Phase II to Phase III Study
CTO #: 103295
NCT Number: NCT04137107
Phase: I/II
Protocol Type: Supportive Care
Age Group: Adults
Disease Sites: Colon, Rectum
Study Objectives: 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.