Actively Recruiting

Age: 21Years +
FEMALE
Healthy Volunteers
NCT03137095

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

Led by University of Rochester · Updated on 2026-04-24

150

Participants Needed

1

Research Sites

544 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 21Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Female with invasive non-metastatic breast cancer (stage I-IIIC)
  • Scheduled to start chemotherapy with Adriamycin and Cytoxan
  • No prior chemotherapy treatment
  • Able to read and speak English
  • 21 years or older
  • Able to provide written informed consent
  • Female control participants within 5 years of patient's age
  • Control participants able to read and speak English
  • Control participants 21 years or older
  • Control participants able to provide written informed consent
Not Eligible

You will not qualify if you...

  • Currently hospitalized or hospitalized within last year for psychiatric illness
  • Diagnosis of neurodegenerative disease (e.g., Alzheimer's, Parkinson's)
  • Presence of central nervous system disease (e.g., movement disorder, multiple sclerosis)
  • History of TIA or stroke within last year or with remaining symptoms
  • Scheduled to receive radiation therapy during chemotherapy
  • Colorblindness
  • Control participants with prior cancer diagnosis or chemotherapy
  • MR safety contraindications for optional sub-study MRI

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

University of Rochester

Rochester, New York, United States, 14642

Actively Recruiting

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Research Team

S

Sara Alberti

CONTACT

T

Tyler Holler

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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