Alliance A221805

Official Title

Duloxetine to Prevent Oxaliplatin-Induced Chemotherapy-Induced Peripheral Neuropathy: A Randomized, Double-Blinded Placebo-Controlled Phase II to Phase III Study.

Study Purpose

To determine if duloxetine prevent numbness, tingling, and/or pain caused by your cancer treatment with oxaliplatin.

Diagnosis

We are asking you to take part in this research study because you are at risk for developing oxaliplatin-induced peripheral neuropathy. Oxaliplatin-induced peripheral neuropathy (also called OIPN) is numbness, tingling or pain, in the hands or feet, due to your cancer treatment with oxaliplatin.

Eligibility

Stage II-III colorectal cancer patients scheduled to receive adjuvant FOLFOX or CAPOX

No pre-existing neuropathy.

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Intervention

Phase II of this study, patients will either receive 30 mg or 60 mg duloxetine every day for up to 17 weeks, or will receive a placebo every day for up to 17 weeks.  

Phase III after completion of Phase II.