Brain Health in Breast Cancer Survivors
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.
Conditions:
🦠 Cognitive Impairment 🦠 Cognitive Function
🗓️ Study Start (Actual) 11 March 2020
🗓️ Primary Completion (Estimated) 15 March 2025
✅ Study Completion (Estimated) 15 March 2026
👥 Enrollment (Estimated) 120
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Los Angeles, California, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 35 Years to 65 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 28 February 2020
  • First Submitted that Met QC Criteria 4 March 2020
  • First Posted 5 March 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 12 April 2024
  • Last Update Posted 16 April 2024
  • Last Verified April 2024