RecruitingNCT03137095

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

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

Sponsor

University of Rochester

Enrollment

150 participants

Start Date

Feb 20, 2017

Study Type

OBSERVATIONAL

Conditions

Breast Cancer Female Cancer-related Cognitive Difficulties

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

Sex: FEMALEMin Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study is examining how chemotherapy affects memory, concentration, and thinking (sometimes called chemo brain) in women with breast cancer, using brain MRI scans and cognitive tests. **You may be eligible if...** - You are a woman diagnosed with invasive breast cancer that has not spread to distant parts of the body (Stage I-IIIC) - You are scheduled to start chemotherapy with Adriamycin (doxorubicin) and Cytoxan (cyclophosphamide) - You have not received chemotherapy before - You are 21 years old or older - You can speak and read English **You may NOT be eligible if...** - You have been hospitalized for a psychiatric illness in the past year - You have previously received chemotherapy - You have a condition that would prevent safe MRI scanning (if participating in the optional brain imaging part) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERCognitive testing

computerized and paper-based cognitive tests that assess memory, executive function, processing speed and concentration performed at Assessments 1, 3, 4.5 \& 5.

OTHERResearch Brain MRI

Optional sub-study participation includes undergoing research brain MRI to obtain structural and functional brain images at Assessment 4.5 and 6.

Locations(1)

University of Rochester

Rochester, New York, United States

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