drugset / Trial / NCT01615055

Fluoxetine Prevention Trial

NCT01615055

RandomizedParallel-groupQuadruple-blindPrevention

Summary

Many cancer survivors are experiencing problems with memory and other cognitive abilities following cancer treatment. Little is known concerning the contributions of potentially preventive therapies on cognitive function, but animal studies have pointed to the potential value of the medication fluoxetine in this context. We aim to determine whether six months of fluoxetine therapy can preserve brain function in patients who have undergone chemotherapy, and examine potential biological mechanisms for its protective effects in humans. If use of fluoxetine in cancer patients can be validated in this manner, it will represent the first drug demonstrated to prevent cerebral dysfunction associated with exposure to chemotherapy. Moreover, as this involves an agent that is already FDA-cleared for other indications, widely commercially available throughout the U.S. and other parts of the world, and relatively inexpensive since it is obtainable in generic formulations, it would represent a pharmacologic approach that is amenable to rapid translation to the clinical setting.

Timeline

Start
2018-06
Primary completion
2020-10
Completion
2020-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Fluoxetine Small molecule 20 mg Oral
Subject Fluoxetine Small molecule 40 mg Oral

Indications