Brain Health in Breast Cancer Survivors
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|ClinicalTrials.gov Identifier: NCT04297020|
Recruitment Status : Recruiting
First Posted : March 5, 2020
Last Update Posted : July 23, 2020
|Condition or disease|
|Cognitive Impairment Cognitive Function|
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 fMRI measures to assess the effects of ET on brain function.
This study is a cross-sectional study in a 2x2 factorial design comparing menopausal status (pre and post) and patient group (breast cancer survivors on ET and healthy controls matched on age, race, education, and time since final menstrual period (post only)). The investigators will use sensitive fMRI measures of brain activity during a working memory task - measures successfully used to reveal the effects of menopause and estrogen changes in healthy women, but yet to be extensively used to study the effects of ET.
|Study Type :||Observational|
|Estimated Enrollment :||120 participants|
|Official Title:||Brain Health in Breast Cancer Survivors: Interaction of Menopause and Endocrine Therapy|
|Actual Study Start Date :||March 11, 2020|
|Estimated Primary Completion Date :||March 15, 2024|
|Estimated Study Completion Date :||March 15, 2025|
Pre-menopausal BCS + ET
Pre-menopausal Breast Cancer Survivor (BCS) who have undergone Endocrine Therapy (ET)
Post-menopausal BCS + ET
Post-menopausal Breast Cancer Survivor (BCS) who have undergone Endocrine Therapy (ET)
Pre-menopausal Healthy Control
Pre-menopausal healthy control group
Post-menopausal Healthy Control
Post-menopausal healthy control group
- Brain activity comparison between breast cancer survivors undergoing endocrine therapy and healthy matched control subject. [ Time Frame: Day 1 ]To compare brain activity using fMRI during a working memory task between breast cancer survivors on ET and matched healthy controls, and examine the interaction of menopausal status.
- Cognitive function comparison between breast cancer survivors undergoing endocrine therapy and healthy matched control subject. [ Time Frame: Day 1 ]To compare cognitive function between breast cancer survivors on ET and matched healthy controls, and examine the interaction of menopausal status.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04297020
|Contact: Kathleen Van Dyk, PhD||310 825-2719||KVanDyk@mednet.ucla.edu|
|United States, California|
|University of California at Los Angeles||Recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Kathleen Van Dyk 310-825-2719 firstname.lastname@example.org|
|Principal Investigator:||Kathleen Van Dyk, PhD||University of California at Los Angeles|