20-230 - ALLIANCE A221805 - Duloxetine to Prevent Oxaliplatin-Induced Peripheral Neuropathy in Patients With Stage II-III Colorectal CancerStatus: open
ALLIANCE A221805 - Duloxetine to Prevent Oxaliplatin-Induced Chemotherapy-Induced Peripheral Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Phase II to Phase III Study
Prevent peripheral neuropathy in patients being treated with chemotherapy
This study will consist of stage II-III colorectal cancer patients scheduled to receive oxaliplatin as part of their cancer treatment. This treatment often causes what is known as Oxaliplatin-induced peripheral neuropathy (OIPN) which is numbness, tingling or pain, in the hands or feet, due to treatment with oxaliplatin. There are no known treatments to prevent OIPN. The usual approach for patients who develop OIPN is to reduce or stop oxaliplatin treatment, if the OIPN gets too bad, and begin treatment with medication after painful OIPN has already developed. The purpose of this study is to test if the drug duloxetine will keep patients from getting OIPN and to find out if duloxetine is better than the usual approach (no medication for OIPN). To do this, the researchers will be looking to see if duloxetine (at dose of 30 mg or 60 mg) prevents OIPN when compared to placebo. A placebo is a capsule that looks like the study drug, but contains no medication. Duloxetine has been approved by the FDA for treating diabetes induced peripheral neuropathy, but duloxetine is not FDA approved for chemotherapy-induced peripheral neuropathy.