Brain Health in Breast Cancer Survivors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-11

Study Completion Date

2027-03-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cognitive Impairment Cognitive Function

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Pre-menopausal BCS + ET

Pre-menopausal Breast Cancer Survivor (BCS) who have undergone Endocrine Therapy (ET)

No interventions assigned to this group

Post-menopausal BCS + ET

Post-menopausal Breast Cancer Survivor (BCS) who have undergone Endocrine Therapy (ET)

No interventions assigned to this group

Pre-menopausal Healthy Control

Pre-menopausal healthy control group

No interventions assigned to this group

Post-menopausal Healthy Control

Post-menopausal healthy control group

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes