Clinical Study

A221805 Duloxetine To Prevent Oxaliplatin-Induced Chemotherapy-Induced Peripheral Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Phase II To Phase III Study

Posted Date: Aug 3, 2021

  • Investigator: Jordan Kharofa
  • Specialties: Cancer, Colorectal Cancer, Oncology
  • Type of Study: Drug

This phase II/III trial will study 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. Efficacy will be measured by Prevention of sensory oxaliplatin-induced peripheral neuropathy (OIPN) response (Phase II), Prevention of sensory oxaliplatin-induced peripheral neuropathy (OIPN) response (Phase III), and Chronic neuropathic pain response (Phase III).


Eastern Cooperative Oncology Group (Ecog) Performance Status 0-2. Calculated Creatinine Clearance > 30 Ml/Min. Aspartate Aminotransferases (Ast)/Serum Glutamic-Oxaloacetic Transaminase (Sgot) =< 3 X Upper Limit Of Normal (Uln). No Prior Neurotoxic Chemotherapy. No Pre-Existing Clinical Or Pre-Clinical Peripheral Neuropathy From Any Cause. No History Of Seizure Disorder. No History Of Narrow-Angle Glaucoma. No Symptoms Of Or History Of Schizophrenia, Bipolar Disease, Suicidal Thoughts And/Or A Major Depression. No Serious Eating Disorder Such As Bulimia Or Anorexia. No Known Diagnosis Of Ethanol (Etoh) Addiction/Dependence Within The Past 10 Years.


Colorectal, Neuropathy

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Uc Cancer Center

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