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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Cognitive function (memory, concentration, attentiveness) will be assessed by computerized cognitive assessments and associated with inflammation and neurotoxicity markers
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •, 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
排除标准
- •, 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
研究组 & 干预措施
Breast Cancer Patient Participants
Female breast cancer patients receiving chemotherapy
干预措施: Cognitive testing (Other)
Breast Cancer Patient Participants
Female breast cancer patients receiving chemotherapy
干预措施: Research Brain MRI (Other)
Healthy, age-matched, female participants
Healthy, female, age-matched participants
干预措施: Cognitive testing (Other)
Healthy, age-matched, female participants
Healthy, female, age-matched participants
干预措施: Research Brain MRI (Other)
结局指标
主要结局
Cognitive function (memory, concentration, attentiveness) will be assessed by computerized cognitive assessments and associated with inflammation and neurotoxicity markers
时间窗: 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
次要结局
未报告次要终点
研究者
Michelle Janelsins, PhD, MPH
Assistant Professor
University of Rochester