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

NCT03137095 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2026-04-24

No results posted yet for this study

Summary

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

  • Cancer Related Cognitive Difficulties
  • Breast Cancer Female

Interventions

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.

Sponsors & Collaborators

  • University of Rochester

    lead OTHER

Principal Investigators

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

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-02-20
Primary Completion
2027-07-31
Completion
2027-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03137095 on ClinicalTrials.gov