Effects of Chemotherapy on Cognitive Function in Breast Cancer Patients & Non-Cancer Control Subjects With Optional Sub-Study Research Brain MRI

Study Overview
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Brief Summary
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Study is enrolling newly diagnosed breast cancer patients about to start chemotherapy and age-matched control participants. The investigator is trying to better understand the prevalence of cognitive difficulties in cancer patients receiving chemotherapy compared to the general population as well as what biological mechanisms may play a role in the development of these difficulties. Patients will be asked to complete six assessments over the course of approximately 5 months. Assessments 1,3, 4.5 and 5 include computerized and paper and pencil cognitive testing as well as blood draws. Assessments 2 and 4 only involve the collection of a blood sample. An optional sub study is offered after Assessment 1. It involves a research brain MRI at Assessment 4.5 and cognitive testing and another research brain MRI at Assessment 6.

Official Title
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Longitudinal Pilot Mechanistic Study of the Effects of Chemotherapy on Cognitive Function in Breast Cancer Patients and Non-Cancer Control Participants - Optional Sub-Study: Research Brain MRI

Conditions
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Cancer Related Cognitive Difficulties, Breast Cancer Female

Intervention / Treatment
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* Other: Cognitive testing
* Other: Research Brain MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria, Breast Cancer Patient Participants: Females with a diagnosis of invasive non-metastatic breast cancer (stage I-IIIC) Scheduled to begin a course of chemotherapy with Adriamycin and Cytoxan Chemotherapy naïve Able to speak and read English 21 years or older Give written informed consent Exclusion Criteria, Breast Cancer Patient Participants: Must not be currently hospitalized or have been hospitalized within the last year for a psychiatric illness Must not be diagnosed with a neurodegenerative disease (e.g., Alzheimer's disease, Parkinson's disease) Must not have any Central Nervous System disease (e.g., movement disorder, multiple sclerosis) Subjects could have had a TIA (transient ischemic attack) or stroke in the past if the TIA or stroke was greater than 1 year ago and the subject does not have any remaining symptoms Must not be scheduled to receive concurrent radiation treatment while receiving chemotherapy. Must not be colorblind Inclusion Criteria, Control Participants: Must be female and within 5 years of the age of the subject receiving chemotherapy Able to speak and read English Give written informed consent 21 years or older Exclusion Criteria, Control Participants: Must not be currently hospitalized or have been hospitalized within the last year for a psychiatric illness Must not be diagnosed with a neurodegenerative disease (e.g. Alzheimer's disease, Parkinson's disease) Must not have Central Nervous System disease (e.g., movement disorder, multiple sclerosis) Subjects could have had a TIA (transient ischemic attack) or stroke in the past if the TIA or stroke was greater than 1 year ago and the subject does not have any remaining symptoms Must not have been diagnosed with cancer or previously have received chemotherapy Must not be colorblind For optional sub-study: MR safety assessed via Rochester Center for Brain Imaging Magnetic Resonance (MR) Safety Screening Form to confirm eligibility to participate

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast Cancer Patient Participants<br>Female breast cancer patients receiving chemotherapy | Other: Cognitive testing<br>* computerized and paper-based cognitive tests that assess memory, executive function, processing speed and concentration performed at Assessments 1, 3, 4.5 & 5.<br>Other: Research Brain MRI<br>* Optional sub-study participation includes undergoing research brain MRI to obtain structural and functional brain images at Assessment 4.5 and 6.<br>|
| Healthy, age-matched, female participants<br>Healthy, female, age-matched participants | Other: Cognitive testing<br>* computerized and paper-based cognitive tests that assess memory, executive function, processing speed and concentration performed at Assessments 1, 3, 4.5 & 5.<br>Other: Research Brain MRI<br>* Optional sub-study participation includes undergoing research brain MRI to obtain structural and functional brain images at Assessment 4.5 and 6.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive function (memory, concentration, attentiveness) will be assessed by computerized cognitive assessments and associated with inflammation and neurotoxicity markers | Change scores from baseline will be computed for each cognitive measure as well as each mechanistic marker | During chemotherapy and 1 month post-chemotherapy; Approximately 3 - 5 months |