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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01NR014182-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | healthy, cognitively normal subjects |
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| Measure | Description | Time Frame |
|---|---|---|
| Rates of change in cognitive function from before treatment to after treatment initiation | Measured using a neuropsychological test battery | approximately 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of change of brain structure from before treatment to after treatment initiation | Measured using structural MRI scan | approximately 6 months |
| Rates of change of brain function from before treatment to after treatment initiation |
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Inclusion Criteria:
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
Ineligibility for MRI scanning, including but not limited to:
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.
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Participants will be recruited from the following sites, all affiliated with Northwestern University Feinberg School of Medicine (NUFSM): a) outpatient facility at Galter Pavilion of Northwestern Medicine; b) Maggie Daley Center for Women's Cancer Care at Prentice Women's Hospital; and c) Lynn Sage Comprehensive Breast Cancer Center at Prentice Women's Hospital.
Participants will also be recruited a) via advertisement in local newspapers, craigslist, Robert H. Lurie Comprehensive Cancer Center (RHLCC) Cancer Survivorship Institute website, and at community programs that serve cancer patients, including hospitals and support groups; and b) from community educational events sponsored by RHLCC, Women's Health Research Institute, and Cognitive Neurology and Alzheimer's Disease Center (CNADC).
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| Name | Affiliation | Role |
|---|---|---|
| Lei Wang, PhD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Measured using a functional MRI scan
| approximately 6 months |
| D017437 |
| Skin and Connective Tissue Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |