NCT04297020 Brain Health in Breast Cancer Survivors
| NCT ID | NCT04297020 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jonsson Comprehensive Cancer Center |
| Condition | Cognitive Impairment |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2020-03-11 |
| Primary Completion | 2027-03-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2020-03-11 with a primary completion date of 2027-03-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Kathleen Van Dyk, PhD
PRINCIPAL INVESTIGATOR
University of California at Los Angeles
Frequently Asked Questions
Who can join the NCT04297020 clinical trial?
This trial is open to female participants only, aged 35 Years or older, up to 65 Years, studying Cognitive Impairment. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04297020 currently recruiting?
Yes, NCT04297020 is actively recruiting participants. Contact the research team at KVanDyk@mednet.ucla.edu for enrollment information.
Where is the NCT04297020 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT04297020 clinical trial?
NCT04297020 is sponsored by Jonsson Comprehensive Cancer Center. The principal investigator is Kathleen Van Dyk, PhD at University of California at Los Angeles. The trial plans to enroll 120 participants.