Understanding how chemotherapy affects cognitive function in breast cancer patients
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
This study looks at how chemotherapy affects thinking and memory in newly diagnosed breast cancer patients compared to people without cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 21 Years and up |
| Sex | Female |
| Sponsor | University of Rochester Academic / other |
| Drugs / interventions | chemotherapy, radiation, Cytoxan |
| Locations | 1 site (Rochester, New York) |
| Trial ID | NCT03137095 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are females aged 21 and older with a diagnosis of invasive non-metastatic breast cancer scheduled to begin chemotherapy.
Not a fit: Patients with psychiatric illnesses, neurodegenerative diseases, or those currently hospitalized may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and management of cognitive difficulties in breast cancer patients undergoing chemotherapy.
How similar studies have performed: Other studies have explored cognitive effects of chemotherapy, but this specific approach focusing on biological mechanisms is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rochester, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.