Clinical Trial IDNCT04137107
Lead SponsorAlliance for Clinical Trials in Oncology
Principal Investigator
Start Date2020-01-01
Completion Date2025-12-01
Study TypeInterventional
PhasePhase 2/Phase 3
StatusNot yet recruiting

Purpose

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.

Conditions

ConditionInterventionPhase
Stage II Colorectal Cancer AJCC v8, Stage III Colorectal Cancer AJCC v8Drug: Oxaliplatin, Drug: Duloxetine Hydrochloride, Drug: Duloxetine, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Other: PlaceboPhase 2/Phase 3

Eligibility

AgeGenderAccepts Healthy Volunteers
25 Years and older.AllNo