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Understanding Cognitive Changes in Breast Cancer Patients Receiving Chemotherapy

This observational study is looking at how chemotherapy affects thinking and memory in women with breast cancer. Researchers want to understand why some women experience "chemo brain" (cancer-related cognitive difficulties) when treated with Adriamycin and Cytoxan, and what biological reasons might be behind it. They will compare breast cancer patients who are about to start chemotherapy with women who do not have cancer. If you join, you'll have cognitive tests (computer and paper-based) and blood draws over about 5 months. There's also an optional part where you can get a research brain MRI (magnetic resonance imaging) to look at your brain. The study aims to see if cognitive function (memory, concentration, attentiveness) changes during and after chemotherapy and if it's linked to inflammation or nerve damage.

Study design
This is an observational study involving 150 participants, comparing newly diagnosed breast cancer patients with healthy control subjects.
What's involved
You would complete six assessments over approximately 5 months, including cognitive testing, blood draws, and an optional research brain MRI.
Compensation
Not stated in the trial record.
Follow-up
Cognitive function and markers will be assessed during chemotherapy and 1 month post-chemotherapy, approximately 3-5 months total.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03137095

Effects of Chemotherapy on Cognitive Function in Breast Cancer Patients & Non-Cancer Control Subjects With Optional Sub-Study Research Brain MRI

Recruiting
Not specifiedAges 21+Observational
University of Rochester
~150 participants
Updated 2026-04-24 on ClinicalTrials.gov
What's tested:Cognitive testingResearch Brain MRI

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cognitive function (memory, concentration, attentiveness) will be assessed by computerized cognitive assessments and associated with inflammation and neurotoxicity markers
Measured over During chemotherapy and 1 month post-chemotherapy; Approximately 3 - 5 months

Conditions

Cancer Related Cognitive Difficulties
Breast Cancer Female

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Michelle C. Janelsins, Ph.D.,M.P.H. · PRINCIPAL_INVESTIGATOR · University of Rochester

Who to contact

Sara Alberti
[email protected]
585-273-3998
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
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

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
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

What this trial measures

  • Cognitive function (memory, concentration, attentiveness) will be assessed by computerized cognitive assessments and associated with inflammation and neurotoxicity markersDuring chemotherapy and 1 month post-chemotherapy; Approximately 3 - 5 months

    Change scores from baseline will be computed for each cognitive measure as well as each mechanistic marker