Understanding how chemotherapy affects cognitive function in breast cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study enrolls newly diagnosed breast cancer patients who are about to start chemotherapy, along with age-matched control participants, to investigate the prevalence of cognitive difficulties associated with chemotherapy. Participants will undergo a series of cognitive assessments and blood draws over approximately five months to explore the biological mechanisms behind these cognitive challenges. An optional sub-study includes research brain MRIs to further examine brain function and structure in relation to cognitive performance. The study aims to provide insights into how chemotherapy impacts cognitive health in cancer patients compared to the general population.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Rochester
  Rochester, New York, United States Recruiting

Study contacts

• Principal investigator: Michelle C. Janelsins, Ph.D.,M.P.H. — University of Rochester
• Study coordinator: Sara Alberti
• Email: Sara_Alberti@urmc.rochester.edu
• Phone: 585-273-3998

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.