Brain Health in Breast Cancer Survivors
Recruiting · NCT04297020 · Observational (researchers observe without assigning treatment) · Lead sponsor: Jonsson Comprehensive Cancer Center
View the official record on ClinicalTrials.gov →What this trial is about
Endocrine therapy (ET) is widely used to treat hormone receptor positive breast cancer and prevent recurrence by downregulating estrogen function. However, ETs readily cross the blood brain barrier and interfere with the action of estrogen in the brain. Estrogen supports cognition and menopausal status is closely linked to cognitive health in women. This has raised concern that anti-estrogen ETs may affect cognition and brain health in breast cancer survivors. However, evidence across existing studies is inconsistent and these effects remain poorly understood. The incomplete understanding of the effects of ET are likely due to limitations of earlier studies - namely, the under-appreciation of the role of menopausal status and insensitivity of standard cognitive measures. This research project will address these earlier limitations by specifically comparing ET effects by menopausal status, and using highly sensitive, task-related functional magnetic resonance imaging (fMRI) measures to assess the effects of ET on brain function.
Who can take part
Inclusion criteria
- Age 35-65
- Fluent in English
- Adequate vision/hearing to complete testing
Exclusion criteria
- History of major or mild neurocognitive disorder or dementia
- Diagnosis of major neurological condition (e.g., epilepsy, Parkinson's Disease, stroke)
- Diagnosis of a major psychiatric disorder (e.g., bipolar disorder, schizophrenia)
- Untreated/unstable unipolar depression or anxiety
- Prior history of cancer or chemotherapy (for controls, any history)
- History of a learning disorder
- History of head injury with loss of consciousness \>20 minutes
- History of salpingo-oophorectomy or hysterectomy
- A cardiac pacemaker
- Implanted electronic device
- Claustrophobia
- Currently pregnant
- Orbital metal implant or other metallic foreign bodies
- Additional exclusion criteria for controls: current use of a contraceptive agent that interferes with endogenous hormonal fluctuation (e.g., oral contraceptive pill) or precludes determination of menstrual pattern (e.g., hormonally secreting intrauterine device), or current treatment with systemic estrogen replacement therapy.
Where it is running
1 location listed across 1 US state.
- University of California at Los Angeles - Los Angeles, California, United States