Mild Cognitive Impairment in Breast Cancer Patients



Status:Recruiting
Conditions:Breast Cancer, Cancer, Cognitive Studies
Therapuetic Areas:Oncology, Psychiatry / Psychology
Healthy:No
Age Range:40 - 70
Updated:3/15/2019
Start Date:June 2013
End Date:December 2020
Contact:Melody Fairchild, M.A.T.
Email:m-fairchild@northwestern.edu
Phone:312-503-7071

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Hippocampal Predictors of Cognitive Impairment (HippoPCI) in Breast Cancer Patients

The purpose of this study is to improve our understanding of potential changes in size, shape
and activity in some brain areas that can occur in women receiving different types of Breast
Cancer therapy, and how these changes are related to the development of mild cognitive
impairment as the result of these treatments.

This study aims to identify neuroimaging biomarkers for predicting mild cognitive impairment
(MCI) in breast cancer patients receiving adjuvant chemo and/or hormonal therapy by examining
hippocampal-cortical neurocircuitry. Adjuvant therapies increase long-term survival, but
produce changes in cognitive function in 30% (up to 70%) of women on average with breast
cancer. Cognitive decline negatively impacts quality of life in patients and their
supporters. Therefore, early identification of patients at risk for developing
treatment-related cognitive impairment is needed to develop potential prevention or treatment
options and prevent further decline. Our recent work demonstrates that patients receiving
adjuvant hormonal treatment exhibit decline in cognition as soon as three months post
treatment. Although neuroimaging studies have identified brain changes associated with
chemotherapy ("chemo brain", no investigation has assessed the type and severity of such
changes following hormonal therapy, nor has any study determined which individuals are at
greatest risk for cognitive impairment.

Our central hypothesis is that measures of the hippocampal-cortical integrity can be used to
predict cognitive decline, and changes of specific domains of cognitive performance in
patients receiving adjuvant therapy over time will be related to changes in specific
components of this circuitry over time.

Inclusion Criteria:

- Female, within the age range of 40-70

- HT Patients - any stage of breast cancer without brain metastasis, will undergo
hormonal therapy without chemotherapy

- CT and HT Patients - any stage of breast cancer without brain metastasis, will undergo
chemotherapy and hormonal therapy

- CT Patients - any stage of breast cancer without brain metastasis, has undergone
surgery prior to screening, will undergo chemotherapy without hormonal therapy

- RT or NT Patients - any stage of breast cancer without brain metastasis, will not
undergo chemotherapy or hormonal therapy; may undergo radiation therapy or have no
therapy

- Controls - cognitively normal on the basis of annual neuropsychological and research
neurological examinations done as part of the Uniform Data Set (UDS), of the NIA
Alzheimer's Disease Centers (ADC) program, recruited from the NU CNADC Clinical Core.

- All subjects must have given signed, informed consent prior to registration on study.

Exclusion Criteria:

- Individuals who report significant medical, neurologic, or psychiatric illness,
including but not limited to:

- Major depression

- Schizophrenia

- ADHD

- Autism

- Alzheimer's disease

- Dementia

- Obsessive-compulsive disorder

- Post-traumatic stress disorder

- Individuals with an Inventory of Depressive Symptomatology - Self Report (IDS-SR)
score of 30 or higher, since this level of depression could affect cognitive test
performance.

- Brain surgery or head injury

- Individuals reporting previous head injury

- Individuals requiring neurosurgical procedures

- Ineligibility for MRI scanning, including but not limited to:

- Individuals who have non-MRI compatible medical implants or devices

- Individuals who have any potential metal in their bodies

- Individuals who have claustrophobia

- Individuals with permanent makeup

- Individuals reporting consumption of drugs that would affect cognition
(neuropsychiatric or illicit)

- Individuals indicating a history of breast cancer will be excluded from the healthy
control group

- Women who are pregnant or are planning to become pregnant during study.
We found this trial at
1
site
303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Lei Wang, PhD
Phone: 312-503-7071
?
mi
from
Chicago, IL
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