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

Breast Cancer Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03137095
• Other study ID #: 54027
• Status: Recruiting
• Start date: February 20, 2017
• Est. completion date: July 31, 2025

Study information

• Verified date: March 2024
• Source: University of Rochester
• Contact: Sara Alberti
• Phone: 585-273-3998
• Email: Sara_Alberti[@]urmc.rochester.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms
• Cancer Related Cognitive Difficulties

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Research Brain MRI	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
Primary	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