Effects of Chemotherapy on Cognitive Function in Breast Cancer Patients & Non-Cancer Control Subjects With Optional Sub-Study Research Brain MRI
NCT ID: NCT03137095
Last Updated: 2025-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
150 participants
OBSERVATIONAL
2017-02-20
2026-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Breast Cancer Patient Participants
Female breast cancer patients receiving chemotherapy
Cognitive testing
computerized 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
Optional sub-study participation includes undergoing research brain MRI to obtain structural and functional brain images at Assessment 4.5 and 6.
Healthy, age-matched, female participants
Healthy, female, age-matched participants
Cognitive testing
computerized 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
Optional sub-study participation includes undergoing research brain MRI to obtain structural and functional brain images at Assessment 4.5 and 6.
Interventions
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Cognitive testing
computerized 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
Optional sub-study participation includes undergoing research brain MRI to obtain structural and functional brain images at Assessment 4.5 and 6.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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
* 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
21 Years
FEMALE
Yes
Sponsors
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University of Rochester
OTHER
Responsible Party
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Michelle Janelsins, PhD, MPH
Assistant Professor
Principal Investigators
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Michelle C. Janelsins, Ph.D.,M.P.H.
Role: PRINCIPAL_INVESTIGATOR
University of Rochester
Locations
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University of Rochester
Rochester, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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54027
Identifier Type: -
Identifier Source: org_study_id
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