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Recruiting NCT03137095

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

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Trial Parameters

Condition Cancer Related Cognitive Difficulties
Sponsor University of Rochester
Study Type OBSERVATIONAL
Phase N/A
Enrollment 150
Sex FEMALE
Min Age 21 Years
Max Age N/A
Start Date 2017-02-20
Completion 2026-07-31
Interventions
Cognitive testingResearch Brain MRI

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Brief Summary

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.

Eligibility Criteria

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 Inclusi

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