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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 21
Healthy Volunteers: t
View:

• 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

• 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

Locations
United States
New York
University of Rochester
RECRUITING
Rochester
Contact Information
Primary
Sara Alberti
Sara_Alberti@urmc.rochester.edu
585-273-3998
Backup
Tyler Holler
Tyler_Holler@urmc.rochester.edu
585-273-2950
Time Frame
Start Date: 2017-02-20
Estimated Completion Date: 2026-07-31
Participants
Target number of participants: 150
Treatments
Breast Cancer Patient Participants
Female breast cancer patients receiving chemotherapy
Healthy, age-matched, female participants
Healthy, female, age-matched participants
Related Therapeutic Areas
Sponsors
Leads: University of Rochester

This content was sourced from clinicaltrials.gov