NCT03137095 Effects of Chemotherapy on Cognitive Function in Breast Cancer Patients & Non-Cancer Control Subjects With Optional Sub-Study Research Brain MRI
| NCT ID | NCT03137095 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Rochester |
| Condition | Cancer Related Cognitive Difficulties |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2017-02-20 |
| Primary Completion | 2027-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2017-02-20 with a primary completion date of 2027-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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 * Give written informed consent * 21 years or older Exclusion Criteria, Control 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 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
Contact & Investigator
Michelle C. Janelsins, Ph.D.,M.P.H.
PRINCIPAL INVESTIGATOR
University of Rochester
Frequently Asked Questions
Who can join the NCT03137095 clinical trial?
This trial is open to female participants only, aged 21 Years or older, studying Cancer Related Cognitive Difficulties. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03137095 currently recruiting?
Yes, NCT03137095 is actively recruiting participants. Contact the research team at Sara_Alberti@urmc.rochester.edu for enrollment information.
Where is the NCT03137095 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT03137095 clinical trial?
NCT03137095 is sponsored by University of Rochester. The principal investigator is Michelle C. Janelsins, Ph.D.,M.P.H. at University of Rochester. The trial plans to enroll 150 participants.
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