RECRUITING

Brain Health in Breast Cancer Survivors

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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 functional magnetic resonance imaging (fMRI) measures to assess the effects of ET on brain function.

Official Title

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

Quick Facts

Study Start:2020-03-11
Study Completion:2026-03-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04297020

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:35 Years to 65 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 35-65
  2. * Fluent in English
  3. * Adequate vision/hearing to complete testing
  1. * History of major or mild neurocognitive disorder or dementia
  2. * Diagnosis of major neurological condition (e.g., epilepsy, Parkinson's Disease, stroke)
  3. * Diagnosis of a major psychiatric disorder (e.g., bipolar disorder, schizophrenia)
  4. * Untreated/unstable unipolar depression or anxiety
  5. * Prior history of cancer or chemotherapy (for controls, any history)
  6. * History of a learning disorder
  7. * History of head injury with loss of consciousness \>20 minutes
  8. * History of salpingo-oophorectomy or hysterectomy
  9. * A cardiac pacemaker
  10. * Implanted electronic device
  11. * Claustrophobia
  12. * Currently pregnant
  13. * Orbital metal implant or other metallic foreign bodies

Contacts and Locations

Study Contact

Kathleen Van Dyk, PhD
CONTACT
310 825-2719
KVanDyk@mednet.ucla.edu

Principal Investigator

Kathleen Van Dyk, PhD
PRINCIPAL_INVESTIGATOR
University of California at Los Angeles

Study Locations (Sites)

University of California at Los Angeles
Los Angeles, California, 90095
United States

Collaborators and Investigators

Sponsor: Jonsson Comprehensive Cancer Center

  • Kathleen Van Dyk, PhD, PRINCIPAL_INVESTIGATOR, University of California at Los Angeles

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-03-11
Study Completion Date2026-03-15

Study Record Updates

Study Start Date2020-03-11
Study Completion Date2026-03-15

Terms related to this study

Keywords Provided by Researchers

  • Breast cancer
  • endocrine therapy

Additional Relevant MeSH Terms

  • Cognitive Impairment
  • Cognitive Function