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

University of Rochester

Status

Enrolling

Conditions

Cancer Related Cognitive Difficulties

Breast Cancer Female

Treatments

Other: Research Brain MRI

Other: Cognitive testing

Study type

Observational

Funder types

Other

Identifiers

NCT03137095

54027

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

Female

Ages

21+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

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