Recruiting

Chemotherapy

Sponsor:

University of Rochester

Code:

NCT03137095

Conditions

Cancer Related Cognitive Difficulties

Breast Cancer Female

Eligibility Criteria

Sex: Female

Age: 21+

Healthy Volunteers: Accepted

Interventions

Cognitive testing

Research Brain MRI

Study Details

Brief 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

Study ID

NCT03137095

Start date

Feb 20, 2017

Status verified date

Apr, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 21+

Healthy Volunteers: Accepted

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 Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

Breast Cancer Patient Participants

Female breast cancer patients receiving chemotherapy

Healthy, age-matched, female participants

Healthy, female, age-matched participants

Interventions

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.

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Sara Alberti

585-273-3998Sara_Alberti@urmc.rochester.edu

Tyler Holler

585-273-2950Tyler_Holler@urmc.rochester.edu

Locations

University of Rochester

Recruiting

Rochester, New York, United States, 14642

Contacts

Sara Alberti

585-273-3998Sara_Alberti@urmc.rochester.edu

Tyler Holler

585-273-2950Tyler_Holler@urmc.rochester.edu

Principal Investigator:

Michelle C. Janelsins, PhD,MPH

More Information

Sponsor

University of Rochester

Last update posted

Apr 24, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Rochester on 2026-04-24.