Brain Health in Breast Cancer Survivors

Part of paid clinical trials in Los Angeles, California.

Sponsor
Jonsson Comprehensive Cancer Center
Study ID
NCT04297020
Status
Recruiting
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Conditions

  • Cognitive Function
  • Cognitive Impairment

Eligibility Criteria

Sex
FEMALE
Age
35 Years - 65 Years
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
Mar 11, 2020
Status verified
May 2025
Primary completion
Mar 15, 2027
Completion
Mar 15, 2028

Study Design

Enrollment
120 participants (estimated)

Arms

  • Arm: Pre-menopausal BCS + ET
    Pre-menopausal Breast Cancer Survivor (BCS) who have undergone Endocrine Therapy (ET)
  • Arm: Post-menopausal BCS + ET
    Post-menopausal Breast Cancer Survivor (BCS) who have undergone Endocrine Therapy (ET)
  • Arm: Pre-menopausal Healthy Control
    Pre-menopausal healthy control group
  • Arm: Post-menopausal Healthy Control
    Post-menopausal healthy control group

Primary Outcome Measure

Brain activity comparison between breast cancer survivors undergoing endocrine therapy and healthy matched control subject. [ Time Frame: Day 1 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California at Los AngelesLos AngelesCalifornia90095
Kathleen Van Dyk
[email protected]
310-825-2719

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By research site
University of California at Los Angeles· Los Angeles, CA

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