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Cognitive Dysfunction | Fluoxetine Prevention Trial

Cognitive Dysfunction research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Cognitive Dysfunction

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Fluoxetine20-40 mg fluoxetine po qd for 6 months

Other:Placebo20-40 mg pharmacologically inactive tablets for 6 months

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Fluoxetine tablets

Placebo tablets

Study Status

Withdrawn

Start Date: June 2018

Completed Date: October 2020

Phase: Early Phase 1

Type: Interventional

Design:

Primary Outcome: Change from baseline in regional cerebral metabolism

Secondary Outcome: Durability of the protective effect of fluoxetine

Study sponsors, principal investigator, and references

Principal Investigator: Daniel H. Silverman, M.D., Ph.D.

Lead Sponsor: University of California, Los Angeles

Collaborator: City of Hope Medical Center

More information:https://clinicaltrials.gov/show/NCT01615055

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