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

April 22, 2026 updated by: Michelle Janelsins, PhD, MPH, University of Rochester

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Female breast cancer patients with a diagnosis of invasive non-metastatic breast cancer (stage I -IIIC) and age-matched, health female participants

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Breast Cancer Patient Participants
Female breast cancer patients receiving chemotherapy
Other: Cognitive testing
computerized and paper-based cognitive tests that assess memory, executive function, processing speed and concentration performed at Assessments 1, 3, 4.5 & 5.
Other: Research Brain MRI
Optional sub-study participation includes undergoing research brain MRI to obtain structural and functional brain images at Assessment 4.5 and 6.
Healthy, age-matched, female participants
Healthy, female, age-matched participants
Other: Cognitive testing
computerized and paper-based cognitive tests that assess memory, executive function, processing speed and concentration performed at Assessments 1, 3, 4.5 & 5.
Other: Research Brain MRI
Optional sub-study participation includes undergoing research brain MRI to obtain structural and functional brain images at Assessment 4.5 and 6.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive function (memory, concentration, attentiveness) will be assessed by computerized cognitive assessments and associated with inflammation and neurotoxicity markers
Time Frame: During 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
During chemotherapy and 1 month post-chemotherapy; Approximately 3 - 5 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Research Brain MRI
Time Frame: After 4 cycles Adriamycin/Cytoxan (each cycle of AC is 14 days) and within 1 month post additional chemotherapy treatment
MRI brain imaging to obtain structural and connectivity data via fMRI (brain function), T1MRI (brain structure) and DTI (white matter related microstructure in brain) to determine if there are changes within the brain related to cognitive performance, symptoms, immune and other biologic factors
After 4 cycles Adriamycin/Cytoxan (each cycle of AC is 14 days) and within 1 month post additional chemotherapy treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Investigators

  • Principal Investigator: Michelle C. Janelsins, Ph.D.,M.P.H., University of Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2017

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2027

Study Registration Dates

First Submitted

April 27, 2017

First Submitted That Met QC Criteria

April 27, 2017

First Posted (Actual)

May 2, 2017

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 54027

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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