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

This trial accepts healthy volunteers

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 population

Female breast cancer patients with a diagnosis of invasive non-metastatic breast cancer (stage I -IIIC) and age-matched, health female participants

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Cognitive testing

    Other intervention

    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 intervention

    Optional sub-study participation includes undergoing research brain MRI to obtain structural and functional brain images at Assessment 4.5 and 6.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Breast Cancer Patient Participants2 interventions
Group B: Healthy, age-matched, female participants2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
During chemotherapy and 1 month post-chemotherapy; Approximately 3 - 5 months

Secondary outcomes

Other outcomes

1

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

Time frame
After 4 cycles Adriamycin/Cytoxan (each cycle of AC is 14 days) and within 1 month post additional chemotherapy treatment

Sponsors and contacts

Click on the lead sponsor to view all of their trials.