What this study is
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.
What's being tested
- Cognitive testing
Intervention · OTHER
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
Intervention · OTHER
Optional sub-study participation includes undergoing research brain MRI to obtain structural and functional brain images at Assessment 4.5 and 6.
Study details
- Official title
- 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
- Conditions
- Cancer Related Cognitive Difficulties · Breast Cancer Female
- Enrolling
- 150 people
- Starts
- 2017-02-20
- Est. completion
- 2027-07-31
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 21 Years and overSex FEMALEHealthy volunteers Accepted, Breast Cancer Patient Participants
You may qualify if
- 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
You can't join if
- 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
, Control Participants
You may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Rochester
Rochester, New York, United States
- Sara Alberti · Contact585-273-3998Sara_Alberti@urmc.rochester.edu
- Tyler Holler · Contact585-273-2950Tyler_Holler@urmc.rochester.edu
- Michelle C. Janelsins, PhD,MPH · Principal investigator
Recruiting
Study team
Sponsor
University of Rochester
Study ID 54027
Principal investigator
Michelle C. Janelsins, Ph.D.,M.P.H.
University of Rochester
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.