About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Female breast cancer patients with a diagnosis of invasive non-metastatic breast cancer (stage I -IIIC) and age-matched, health female participants
Trial design
Case-control
Prospective
Treatments tested in this trial
Cognitive testing
Other interventioncomputerized and paper-based cognitive tests that assess memory, executive function, processing speed and concentration performed at Assessments 1, 3, 4.5 \& 5.
Research Brain MRI
Other interventionOptional sub-study participation includes undergoing research brain MRI to obtain structural and functional brain images at Assessment 4.5 and 6.
Treatment groups
Trial outcomes
Primary outcomes
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
Other outcomes
Research Brain MRI
MRI brain imaging to obtain structural and connectivity data via fMRI (brain function), T1MRI (brain structure) and DTI (white matter related microstructure in brain) to determine if there are changes within the brain related to cognitive performance, symptoms, immune and other biologic factors
Sponsors and contacts
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