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

Part of paid clinical trials in Rochester, New York.

Sponsor
University of Rochester
Study ID
NCT03137095
Status
Recruiting
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Conditions

  • Breast Cancer Female
  • Cancer Related Cognitive Difficulties

Eligibility Criteria

Sex
FEMALE
Age
21 Years - N/A
Healthy Volunteers
Accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Feb 20, 2017
Status verified
Apr 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
150 participants (estimated)

Arms

  • Arm: Breast Cancer Patient Participants
    Female breast cancer patients receiving chemotherapy
  • Arm: Healthy, age-matched, female participants
    Healthy, female, age-matched participants

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

Locations (1)

FacilityCityStateZIPSite coordinators
University of RochesterRochesterNew York14642
Sara Alberti
[email protected]
585-273-3998
Tyler Holler
[email protected]
585-273-2950
Michelle C. Janelsins, PhD,MPH (PRINCIPAL_INVESTIGATOR)

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