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Duloxetine to Prevent Oxaliplatin-Induced Chemotherapy-Induced Peripheral Neuropathy: A Randomized, Double-Blinded Placebo-Controlled Phase II to Phase III Study.
To determine if duloxetine prevent numbness, tingling, and/or pain caused by your cancer treatment with oxaliplatin.
DiagnosisWe 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.
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.
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.
For more information, visit ClinicalTrials.gov