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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age21+
SponsorUniversity of Rochester

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Cognitive testing
  • Research Brain MRI

Treatment groups

150 Participants
are divided into 2 treatment groups

Sponsors and collaborators