Integrated PET/MRI Study of Cognitive Impairment in Premenopausal Breast Cancer Patients After Chemotherapy or Endocrine Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change of attention, verbal short term and working memory
研究概览
简要总结
To explore the cognitive impairment caused by chemotherapy and endocrine therapy in premenopausal breast cancer patients and to find biomarkers with early predictive effect on this cognitive impairment by using multimodal integrated PET/MRI technology combined with psychobehavioral technology.
详细描述
Breast cancer is the most common type of cancer in women worldwide, and cancer-related cognitive impairment (CRCI) has become one of the most concerning clinical problems in breast cancer treatment. This project intends to use the combination of advanced PET/MRI technology and psycho-behavioral methods to observe the cognitive impairment and the changes in brain structure, function and glucose metabolism caused by chemotherapy and endocrine therapy in premenopausal breast cancer patients, then looking for possible predictors, through early identification of patients at risk of cognitive decline after chemotherapy or endocrine therapy, to provide a scientific basis for the rational selection of breast cancer treatment plans in the future.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients with primary stage I-II breast cancer.
- •Premenopausal women (menopausal status determined by National Comprehensive Cancer Network Breast Cancer Guidelines criteria).
- •No treatment other than surgery has been started (if neoadjuvant chemotherapy is required before surgery, enroll before chemotherapy starts).
- •Eastern Cooperative Oncology Group score of 0-1 points.
- •Can understand and complete various scales.
- •Right handedness.
- •Female subjects of childbearing potential must be willing to use a medically-approved high-efficiency contraceptive method (eg, intra-uterine device, birth control pill, or condom) for the duration of the study.
- •Sign the informed consent and voluntarily participate in this clinical observation.
排除标准
- •Central nervous system (CNS) disease, history of malignancy, chronic loss of consciousness, head trauma, and any disease affecting cognitive function.
- •Current or former epilepsy, dementia, or learning disabilities.
- •Past psychiatric history.
- •Past history of malignancy.
- •MRI related contraindications: pacemakers, defibrillators, hearing aids, insulin pumps, drug dose control devices and other metal implants; patients with severe hyperthermia; patients with claustrophobia.
结局指标
主要结局
Change of attention, verbal short term and working memory
时间窗: Baseline, 6,18,30 months later
Attention, verbal short term and working memory scores will be assessed with Digit span.The minimum value is 0, and the maximum value is 12. The higher scores mean a better outcome.
Change of life quality.
时间窗: Baseline, 6,18,30 months later
Quality of life scores will be assessed with Quality-of-Life Questionnaire C30. The minimum value is 30, and the maximum value is 126. The higher scores mean a worse outcome.
Change of gray matter volume of whole brain
时间窗: Baseline, 6,18,30 months later
Gray matter volume will be measured with magnetic resonance imaging (high resolution T1-weighted image)
Change of white matter integrity of whole brain.
时间窗: Baseline, 6,18,30 months later
Fractional anisotropy, axial diffusivity and radial diffusivity will be measured with magnetic resonance imaging (diffusion tensor imaging)
Change of metabolism of glucose in the brain
时间窗: Baseline, 6,18,30 months later
Accumulation of 18F-fluorodeoxyglucose(18F-FDG) will be analyzed by time-related Positron emission tomography
Change of sleep
时间窗: Baseline, 6,18,30 months later
Sleep scores will be assessed with Pittsburgh sleep quality index.The minimum value is 9, and the maximum value is 36. The higher scores mean a worse outcome.
Change of functional connectivity of whole brain
时间窗: Baseline, 6,18,30 months later
Functional connectivity will be measured with magnetic resonance imaging based on blood oxygen level dependence
Change of verbal learning and memory
时间窗: Baseline, 6,18,30 months later
Verbal learning and memory scores will be assessed with Hopkins Verbal Learning Test-Revised.The minimum value is 0, and the maximum value is 12. The higher scores mean a better outcome.
Change of fatigue
时间窗: Baseline, 6,18,30 months later
Fatigue scores will be assessed with Fatigue Severity Scale. The minimum value is 9, and the maximum value is 63. The higher scores mean a worse outcome.
Change of information processing speed
时间窗: Baseline, 6,18,30 months later
Information processing speed scores will be assessed with Wechsler Adult Intelligence Scale(WAIS-III) Digit Symbol Coding score.The minimum value is 0, and the maximum value is 90. The higher scores mean a better outcome.
Change of executive function
时间窗: Baseline, 6,18,30 months later
Executive function scores will be assessed with Stroop color-word test.The minimum value is 0, and the maximum value is 50. The higher scores mean a better outcome.
Change of anxiety
时间窗: Baseline, 6,18,30 months later
Anxiety scores will be assessed with Self-Rating Anxiety Scale.The minimum value is 20, and the maximum value is 80. The higher scores mean a worse outcome.
Change of depression
时间窗: Baseline, 6,18,30 months later
Depression scores will be assessed with Self-rating depression scale.The minimum value is 20, and the maximum value is 80. The higher scores mean a worse outcome.
次要结局
- Change of the concentration of serum biomarkers.(Baseline, 6,18,30 months later)