Alzheimer's Disease Education and Referral Center

Mild Cognitive Impairment in Breast Cancer

Mild Cognitive Impairment in Breast Cancer

Overall Status: 
Recruiting
Brief Description: 

This observational study will examine changes in brain-region size, shape, and activity that occur in women with breast cancer and how those changes relate to the development of mild cognitive impairment. Three groups will be compared: women with breast cancer who will undergo hormonal therapy with or without chemotherapy, women with breast cancer who will undergo no therapy or radiation therapy, and healthy female volunteers.

Patient Qualifications: 
Min AgeMax AgeGenderHealthy Volunteers
40 Years
70 Years
Female
Accepts Healthy Volunteers
Inclusion Criteria: 
    • Women at any stage of breast cancer without brain metastasis who have undergone surgery (healthy volunteers also accepted)
    • Postmenopausal or will undergo hormonal therapy
    • Cognitively normal based on annual examinations done as part of the NIA Alzheimer's Disease Centers (ADC) program
    • Recruited from the Northwestern University ADC Clinical Core
Exclusion Criteria: 
    • Significant medical, neurologic, or psychiatric illness such as major depression, schizophrenia, attention deficit hyperactivity disorder, autism, Alzheimer's disease or other dementia, obsessive-compulsive disorder, or post-traumatic stress disorder
    • Inventory of Depressive Symptomatology-Self Report (IDS-SR) score of 30 or higher
    • Left-handedness
    • Brain surgery or head injury, previous head injury, or condition requiring neurosurgical procedures
    • Ineligibility for magnetic resonance imaging, including but not limited to medical implants or devices, potential metal in the body, claustrophobia, or permanent makeup
    • Consumption of neuropsychiatric or illicit drugs that would affect cognition
    • Individuals with a history of breast cancer will be excluded from the healthy control group.
    • Pregnancy
Detailed Description: 

This study aims to identify neuroimaging biomarkers—specifically, measures of the brain's hippocampal-cortical integrity—that can predict mild cognitive impairment in female breast cancer patients who receive chemotherapy and/or hormonal therapy. These therapies increase long-term survival but produce changes in cognitive function, sometimes as soon as 3 months after treatment, in an average of 30 percent of women with breast cancer. Early identification of women at risk for developing treatment-related cognitive impairment is needed to develop potential prevention or treatment options and prevent further decline.

Although neuroimaging studies have identified brain changes associated with chemotherapy ("chemo brain"), none has assessed the type and severity of such changes following hormonal therapy. No study has determined which individuals are at greatest risk for cognitive impairment.

Locations: 
Map Marker CityStateZip CodeStatusPrimary Contact

Geolocation is 41.8925085, -87.6161696

Site
Chicago
Illinois
60611
Recruiting
Name: Jessica Berger, LCSW
Phone: 312-503-4995
Email: jessica.berger1@northwestern.edu
Lead Sponsor: 
Agency
Northwestern University
Collaborator Sponsor: 
Agency
National Institute of Nursing Research (NINR)
Facility Investigators: 
NameRoleAffiliation
Lei Wang, PhD
Principal Investigator
Northwestern University
Study Contact: 
NamePhoneEmail
Jessica Berger
312-503-4995
Melody Fairchild
312-503-7071
Locations
 
 
ClinicalTrials.gov ID 
NCT01949376 (follow link to view full record on ct.gov in new window)
Official Title: 
Hippocampal Predictors of Cognitive Impairment (HippoPCI) in Breast Cancer Patients
Study Start Date: 
June 2013
Study End Date: 
December 2018
Disease Stage: 
Pre-clinical
Early
Enrollment: 
120