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

Recruiting

• Conditions: Cancer Related Cognitive Difficulties; Breast Cancer Female
• Interventions: Other: Cognitive testing; Other: Research Brain MRI

• Registration Number: NCT03137095
• Lead Sponsor: University of Rochester

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-02-20
• Study First Submitted: 2017-04-27
• Study First Submitted QC: 2017-04-27
• Study First Posted: 2017-05-02
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-28
• Last Update Posted: 2024-04-01
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy, age-matched, female participants	Cognitive testing	Healthy, female, age-matched participants
Healthy, age-matched, female participants	Research Brain MRI	Healthy, female, age-matched participants
Breast Cancer Patient Participants	Cognitive testing	Female breast cancer patients receiving chemotherapy
Breast Cancer Patient Participants	Research Brain MRI	Female breast cancer patients receiving chemotherapy

Primary Outcome Measures

Name	Time	Method
Cognitive function (memory, concentration, attentiveness) will be assessed by computerized cognitive assessments and associated with inflammation and neurotoxicity markers	During chemotherapy and 1 month post-chemotherapy; Approximately 3 - 5 months	Change scores from baseline will be computed for each cognitive measure as well as each mechanistic marker

Trial Locations

Locations (1)

University of Rochester; 🇺🇸 Rochester, New York, United States