Investigating brain health in breast cancer survivors undergoing hormone therapy
Brain Health in Breast Cancer Survivors: Interaction of Menopause and Endocrine Therapy
This study is trying to see how hormone therapy affects brain function in breast cancer survivors, especially looking at how menopause plays a role.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 35 Years to 65 Years |
| Sex | Female |
| Sponsor | Jonsson Comprehensive Cancer Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT04297020 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the effects of endocrine therapy on cognitive function in breast cancer survivors, particularly focusing on the role of menopausal status. By employing a cross-sectional, 2x2 factorial design, the study will compare brain activity between survivors on endocrine therapy and healthy controls using advanced fMRI techniques during a working memory task. The research seeks to address inconsistencies in previous studies by considering menopausal status and utilizing sensitive cognitive measures. The findings could provide insights into how hormone therapy impacts brain health in this population.
Who should consider this trial
Good fit: Ideal candidates include women aged 35-65 who are fluent in English and have adequate vision and hearing to complete testing.
Not a fit: Patients with a history of major neurocognitive disorders, major neurological conditions, or prior cancer treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of cognitive health in breast cancer survivors undergoing hormone therapy.
How similar studies have performed: While some studies have explored cognitive effects of hormone therapy, this approach using sensitive fMRI measures in the context of menopausal status is relatively novel.
Eligibility criteria
Show full 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.
Where this trial is running
Los Angeles, California
- University of California at Los Angeles — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Kathleen Van Dyk, PhD — University of California at Los Angeles
- Study coordinator: Kathleen Van Dyk, PhD
- Email: KVanDyk@mednet.ucla.edu
- Phone: 310 825-2719
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.