Study Stopped
Study withdrawn. No participants enrolled.
Fluoxetine Prevention Trial
Prevention of Cognitive Decline After Chemotherapy, With Fluoxetine Treatment
1 other identifier
interventional
N/A
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2018
Typical duration for early_phase_1
2 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 6, 2012
CompletedFirst Posted
Study publicly available on registry
June 8, 2012
CompletedStudy Start
First participant enrolled
June 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2020
CompletedOctober 15, 2018
October 1, 2018
2.3 years
June 6, 2012
October 10, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in regional cerebral metabolism
Baseline and 6 months
Secondary Outcomes (4)
Durability of the protective effect of fluoxetine
6 months and 1 year
Change from baseline in neuropsychological (cognitive, functional) test results
Baseline, 6 months, and 1 year
Correlation between cognitive functioning and cerebral metabolism by correlating neuropsychological testing results with PET imaging
Baseline, 6 months, and 1 year
Correlation between inflammatory cytokines and cerebral metabolism by correlating blood cytokine marker levels with PET imaging
Baseline, 6 months, and 1 year
Study Arms (2)
Fluoxetine tablets
EXPERIMENTALPlacebo tablets
PLACEBO COMPARATORInterventions
20-40 mg pharmacologically inactive tablets for 6 months
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, Los Angeleslead
- City of Hope Medical Centercollaborator
Study Sites (2)
City of Hope
Duarte, California, 91010, United States
UCLA Medical Center
Los Angeles, California, 90024, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel H. Silverman, M.D., Ph.D.
University of California, Los Angeles
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Medical and Molecular Pharmacology
Study Record Dates
First Submitted
June 6, 2012
First Posted
June 8, 2012
Study Start
June 1, 2018
Primary Completion
October 1, 2020
Study Completion
October 1, 2020
Last Updated
October 15, 2018
Record last verified: 2018-10