Chemotherapy-induced Cognitive and Brain Changes in Older Adults With Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Change in cognitive performance scores
研究概览
简要总结
This research study evaluates the effect of chemotherapy on cognition (thinking) and the brain in people with breast cancer.
详细描述
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This study is being done to study effects of chemotherapy (cancer treatment) on the brain and cognition (thinking). "Chemo-brain" is a term sometimes used to refer to effects of chemotherapy on the brain and cognition (thinking).
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This study is being done to test for "chemo-brain" in older adults with breast cancer treated with chemotherapy, and to identify people who are most likely to be affected. The investigators will look at thinking abilities and brain images before and after chemotherapy to see if it can help identify people at risk for cognitive side effects of the treatment, and to better understand effects of treatment on brain structure and function.
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The investigators are looking for participants who have either been recently recently diagnosed breast cancer participant or a healthy volunteer.
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What is involved in the study:
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Memory and Thinking Tests
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Imaging: Either MRI/or MRI and PET Scans
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Breast cancer patients treated with chemotherapy- Group 1 (experimental group)
- •Participants must meet the following criteria on screening examination to be eligible to participate in the behavioral +/- imaging components of study
- •New diagnosis histologically confirmed invasive breast cancer
- •Treatment plan to include chemotherapy
- •Female subjects age ≥ 60 years.
- •Life expectancy ≥ 1 year
- •Karnofsky Performance Score (KPS) ≥ 80
- •Ability to understand and the willingness to sign a written informed consent document.
- •Non-treated breast cancer patient controls- Group 2 (control group)
- •Participants must meet the following criteria on screening examination to be eligible to participate in the behavioral +/- imaging components of study:
- •New diagnosis histologically confirmed invasive breast cancer
- •Treatment plan does not include chemotherapy
- •Age ≥ 60 years.
- •Life expectancy ≥ 1 year
- •Karnofsky Performance Score (KPS) ≥ 80
- •Ability to understand and the willingness to sign a written informed consent document.
- •Healthy control subjects- Group 3 (control group)
- •Participants must meet the following criteria on screening examination to be eligible to participate in the behavioral +/- imaging components of study:
- •Age ≥ 60 years.
- •Life expectancy ≥ 1 year
- •Karnofsky Performance Score (KPS) ≥ 80
- •Ability to understand and the willingness to sign a written informed consent document.
- •Participants with well-controlled vascular risk factors, such as treated hypertension, treated hyperlipidemia or well-controlled Type II diabetes (glucose levels <250) may be included.
- •Serum Pregnancy Testing: STAT quantitative serum hCG pregnancy testing for all women of childbearing potential. Imaging will not start until and unless the test result returns negative.
排除标准
- •Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study:
- •Participants with clinical or radiographic evidence of metastatic CNS disease
- •Subjects with MMSE scores below 24
- •Active or history of major psychiatric disorders such as schizophrenia, schizoaffective disorder, major affective disorder in mid-life, or treatment with ECT (Mild depression that is well treated with stable dose of SSRI antidepressants may be allowed).
- •Substance abuse within the past 2 years
- •Huntington's disease, hydrocephalus or seizure disorder
- •In addition to exclusion criteria above, participants who exhibit any of the following conditions at screening will not be eligible for admission into imaging portion of the study:
- •Participants with contraindications to MRI (i.e., implanted metal including pacemakers, cerebral spinal fluid shunts, aneurysm clips, artificial heart valves, ear implants or metal/foreign objects in the eyes and those with a history of claustrophobia), injuries to the eyes with metal without X-ray documentation that metal was removed
研究组 & 干预措施
ARM 2
Non-treated breast cancer patient control
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Cognitive, functional and subjective assessments (Post enrollment and 6-14 months later
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Imaging (Post Enrollment and at 8-14 months later)
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Magnetic Resonance Imaging (MRI) Scan
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Magnetic Resonance Imaging (MRI) Scan / Positron Emission Tomography (PET) Scan
干预措施: PET Scan (Radiation)
ARM 2
Non-treated breast cancer patient control
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Cognitive, functional and subjective assessments (Post enrollment and 6-14 months later
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Imaging (Post Enrollment and at 8-14 months later)
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Magnetic Resonance Imaging (MRI) Scan
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Magnetic Resonance Imaging (MRI) Scan / Positron Emission Tomography (PET) Scan
干预措施: Cognitive, functional and subjective assessments (Other)
ARM 1
Breast cancer patients treated with chemotherapy
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Cognitive, functional and subjective assessments (Pre and Post Treatment)
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Imaging (Pre and Post Treatment)
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Magnetic Resonance Imaging (MRI) Scan
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Magnetic Resonance Imaging (MRI) Scan / Positron Emission Tomography (PET) Scan
干预措施: PET Scan (Radiation)
ARM 3
Healthy control subjects
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Cognitive, functional and subjective assessments (Post enrollment and 6-14 months later
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Imaging (Post Enrollment and at 8-14 months later)
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Magnetic Resonance Imaging (MRI) Scan
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Magnetic Resonance Imaging (MRI) Scan / Positron Emission Tomography (PET) Scan
干预措施: PET Scan (Radiation)
ARM 3
Healthy control subjects
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Cognitive, functional and subjective assessments (Post enrollment and 6-14 months later
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Imaging (Post Enrollment and at 8-14 months later)
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Magnetic Resonance Imaging (MRI) Scan
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Magnetic Resonance Imaging (MRI) Scan / Positron Emission Tomography (PET) Scan
干预措施: MRI (Device)
ARM 1
Breast cancer patients treated with chemotherapy
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Cognitive, functional and subjective assessments (Pre and Post Treatment)
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Imaging (Pre and Post Treatment)
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Magnetic Resonance Imaging (MRI) Scan
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Magnetic Resonance Imaging (MRI) Scan / Positron Emission Tomography (PET) Scan
干预措施: Cognitive, functional and subjective assessments (Other)
ARM 1
Breast cancer patients treated with chemotherapy
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Cognitive, functional and subjective assessments (Pre and Post Treatment)
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Imaging (Pre and Post Treatment)
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Magnetic Resonance Imaging (MRI) Scan
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Magnetic Resonance Imaging (MRI) Scan / Positron Emission Tomography (PET) Scan
干预措施: MRI (Device)
ARM 2
Non-treated breast cancer patient control
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Cognitive, functional and subjective assessments (Post enrollment and 6-14 months later
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Imaging (Post Enrollment and at 8-14 months later)
-
Magnetic Resonance Imaging (MRI) Scan
-
Magnetic Resonance Imaging (MRI) Scan / Positron Emission Tomography (PET) Scan
干预措施: MRI (Device)
ARM 3
Healthy control subjects
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Cognitive, functional and subjective assessments (Post enrollment and 6-14 months later
-
Imaging (Post Enrollment and at 8-14 months later)
-
Magnetic Resonance Imaging (MRI) Scan
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Magnetic Resonance Imaging (MRI) Scan / Positron Emission Tomography (PET) Scan
干预措施: Cognitive, functional and subjective assessments (Other)
结局指标
主要结局
Change in cognitive performance scores
时间窗: Baseline, immediately after completion of chemo, and 6 months after completion of chemotherapy
次要结局
- Correlation between baseline amyloid accumulation in the brain and change in cognitive performance(Baseline, 6 months after completion of chemotherapy)
- Correlation between baseline tau accumulation in the brain and change in cognitive performance(Baseline, 6 months after completion of chemotherapy)
- Correlation between change in tau accumulation in the brain (from baseline to 6 months after completion of chemotherapy) and change in cognitive performance (from baseline to 6 months after completion of chemotherapy)(Baseline, 6 months after completion of chemotherapy)
研究者
Michael W Parsons
Principal Investigator
Massachusetts General Hospital