Brain Health in Breast Cancer Survivors

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 35 Years - 65 Years
Gender Female
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04297020
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Jonsson Comprehensive Cancer Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Kathleen Van Dyk, PhD
Principal Investigator Affiliation University of California at Los Angeles
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Cognitive Impairment, Cognitive Function
Additional 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 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.

Arms & Interventions

Arms

: 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

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of California at Los Angeles, Los Angeles, California

Status

Recruiting

Address

University of California at Los Angeles

Los Angeles, California, 90095

Site Contact

Kathleen Van Dyk

[email protected]

310-825-2719

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