Fluoxetine Prevention Trial

• Status: Withdrawn
• Trial end date: 2020-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Los Angeles
• Collaborators: Beckman Research Institute; City of Hope Medical Center
• Treatments: Fluoxetine

Criteria

Inclusion Criteria:

• Scheduled to undergo chemotherapy, or has completed chemotherapy no more than a month prior to enrollment, for breast cancer or lymphoma

• Age 21 or above

• Geographically accessible for follow-up in one year

• English language proficient

• Able to provide informed consent

Exclusion Criteria:

• Pregnant

• Evidence of current or past disorder/disease of the central nervous system or any medical condition that might be expected to impact cognitive functioning (e.g. multiple sclerosis)

• History of head trauma with loss of consciousness greater than 30 minutes

• Epilepsy, dementia, or severe learning disability

• Current psychotic-spectrum disorder (e.g. schizophrenia, bipolar disorder, major affective disorder) or current substance abuse or dependence

• History of whole brain irradiation or surgery

• Active diagnosis of autoimmune disorder e.g., systemic lupus erythematosis, rheumatoid arthritis, vasculitis

• Insulin dependent diabetes

• Uncontrolled allergic condition or asthma

• Chronic use of oral steroid medication

• Hormone therapy (estrogen, progestin compounds) other than vaginal estrogen

• Due to the subtleties of neuropsychological test evaluation, including necessity for repeated administration with alternate forms, we must also exclude non-English language proficient subjects.