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
Overview
- Phase
- Not Applicable
- Intervention
- Cognitive testing
- Conditions
- Cancer Related Cognitive Difficulties
- Sponsor
- University of Rochester
- Enrollment
- 150
- Locations
- 2
- Primary Endpoint
- Cognitive function (memory, concentration, attentiveness) will be assessed by computerized cognitive assessments and associated with inflammation and neurotoxicity markers
- Status
- Recruiting
- Last Updated
- 8 days ago
Overview
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.
Investigators
Michelle Janelsins, PhD, MPH
Assistant Professor
University of Rochester
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
- •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
Arms & Interventions
Breast Cancer Patient Participants
Female breast cancer patients receiving chemotherapy
Intervention: Cognitive testing
Breast Cancer Patient Participants
Female breast cancer patients receiving chemotherapy
Intervention: Research Brain MRI
Healthy, age-matched, female participants
Healthy, female, age-matched participants
Intervention: Cognitive testing
Healthy, age-matched, female participants
Healthy, female, age-matched participants
Intervention: Research Brain MRI
Outcomes
Primary Outcomes
Cognitive function (memory, concentration, attentiveness) will be assessed by computerized cognitive assessments and associated with inflammation and neurotoxicity markers
Time Frame: During chemotherapy and 1 month post-chemotherapy; Approximately 3 - 5 months
Change scores from baseline will be computed for each cognitive measure as well as each mechanistic marker