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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 : March 14, 2023
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Study Description
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Brief 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.

Condition or disease
Cognitive Impairment Cognitive Function

Detailed 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.

Study Design
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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pre-menopausal and post-menopausal breast cancer survivors who are undergoing endocrine therapy.
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pre-menopausal and post-menopausal breast cancer survivors who are undergoing endocrine therapy will be compared to healthy control group matched by age, race, education and time since final menstrual period (post only).
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Kathleen Van Dyk, PhD 310 825-2719 KVanDyk@mednet.ucla.edu

Locations
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United States, California
University of California at Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Kathleen Van Dyk    310-825-2719    kvandyk@mednet.ucla.edu   
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Kathleen Van Dyk, PhD University of California at Los Angeles
More Information
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Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT04297020    
Other Study ID Numbers: 19-001004
K08CA241337 ( U.S. NIH Grant/Contract )
NCI-2020-01501 ( Registry Identifier: CTRP )
First Posted: March 5, 2020    Key Record Dates
Last Update Posted: March 14, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jonsson Comprehensive Cancer Center:
Breast cancer
endocrine therapy
Additional relevant MeSH terms:
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Breast Neoplasms
Cognitive Dysfunction
Neoplasms by Site
Neoplasms
Breast Diseases
 Skin Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders