Brain Health in Breast Cancer Survivors
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age35-65
SponsorJonsson Comprehensive Cancer Center
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 35-65
Fluent in English
Adequate vision/hearing to complete testing
Disqualifiers
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
Trial 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).
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
120 Participants
are grouped into 4 trial groupsGroup A: Pre-menopausal BCS + ET
Group B: Post-menopausal BCS + ET
Group C: Pre-menopausal Healthy Control
Group D: Post-menopausal Healthy Control
Trial outcomes
Primary outcomes
1
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.
Time frame
Day 12
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.
Time frame
Day 1Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Jonsson Comprehensive Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov