Brain Health in Breast Cancer Survivors

Cognitive Impairment Clinical Trial

Official title:

Brain Health in Breast Cancer Survivors: Interaction of Menopause and Endocrine Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04297020
• Other study ID #: 19-001004
• Secondary ID: K08CA241337NCI-2
• Status: Recruiting
• Start date: March 11, 2020
• Est. completion date: March 15, 2026

Study information

• Verified date: April 2024
• Source: Jonsson Comprehensive Cancer Center
• Contact: Kathleen Van Dyk, PhD
• Phone: 310 825-2719
• Email: KVanDyk[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 15, 2026
• Est. primary completion date: March 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Cognitive Dysfunction
• Cognitive Function
• Cognitive Impairment

Locations

Country	Name	City	State
United States	University of California at Los Angeles	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain activity comparison between breast cancer survivors undergoing endocrine therapy and healthy matched control subject.	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.	Day 1
Primary	Cognitive function comparison between breast cancer survivors undergoing endocrine therapy and healthy matched control subject.	To compare cognitive function between breast cancer survivors on ET and matched healthy controls, and examine the interaction of menopausal status.	Day 1