Effects of Chemotherapy on Cognitive Function in Breast Cancer Patients and Non-Cancer Control Participants With an Optional Sub-Study: Research Brain MRI
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 10/17/2018 |
| Start Date: | February 20, 2017 |
| End Date: | December 2019 |
| Contact: | Sara Alberti |
| Email: | Sara_Alberti@urmc.rochester.edu |
| Phone: | 585-273-3998 |
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
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.
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.
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
We found this trial at
1
site
60 Crittenden Blvd # 70
Rochester, New York 14642
Rochester, New York 14642
(585) 275-2121
Principal Investigator: Michelle C. Janelsins, PhD,MPH
Phone: 585-273-3998
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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