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Набира участници NCT03137095

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

Заболявания: Cancer Related Cognitive Difficulties Breast Cancer Female

Спонсор: University of Rochester

Налично на: БГ
Обобщение
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.
Кой може да участва
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
Интервенции
Cognitive testing
OTHER
Research Brain MRI
OTHER
Места на провеждане 1
САЩ (1)
University of Rochester
Rochester , New York
Технически детайли
Статус
Набира участници
Вид изследване
OBSERVATIONAL
Пол
Само жени
Минимална възраст
21 Years
Здрави доброволци
Не
Начална дата
20.02.2017
Крайна дата
31.07.2027
Регистрационен номер
NCT03137095
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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