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

NCT03137095 | Recruiting DMC

• 1 other identifier: 54027
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Cognitive function (memory, concentration, attentiveness) will be assessed by computerized cognitive assessments and associated with inflammation and neurotoxicity markers

  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 Outcomes (1)

• Research Brain MRI

  After 4 cycles Adriamycin/Cytoxan (each cycle of AC is 14 days) and within 1 month post additional chemotherapy treatment

Study Arms (2)

Breast Cancer Patient Participants

Female breast cancer patients receiving chemotherapy

Other: Cognitive testing; Other: Research Brain MRI

Healthy, age-matched, female participants

Healthy, female, age-matched participants

Other: Cognitive testing; Other: Research Brain MRI

Interventions

Cognitive testing OTHER

computerized and paper-based cognitive tests that assess memory, executive function, processing speed and concentration performed at Assessments 1, 3, 4.5 \& 5.

Breast Cancer Patient Participants; Healthy, age-matched, female participants

Research Brain MRI OTHER

Optional sub-study participation includes undergoing research brain MRI to obtain structural and functional brain images at Assessment 4.5 and 6.

Breast Cancer Patient Participants; Healthy, age-matched, female participants

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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
• years or older
• Give written informed consent

You may not qualify if:

• 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 be female and within 5 years of the age of the subject receiving chemotherapy
• Able to speak and read English
• Give written informed consent
• years or older
• 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

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, plasma, peripheral blood mononuclear cells (PBMC)

MeSH Terms

Interventions

Neuropsychological Tests

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Michelle C. Janelsins, Ph.D.,M.P.H.

  University of Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Alberti

CONTACT

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

Tyler Holler

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 27, 2017
• First Posted: May 2, 2017
• Study Start: February 20, 2017
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

US (1)