The Effect of Aromatase Inhibition on the Cognitive Function of Older Patients With Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Impact of treatment with an aromatase inhibitor on cognitive function
研究概览
简要总结
RATIONALE: Gathering information about cognitive function over time in postmenopausal women with breast cancer may help doctors learn about the long-term effects of aromatase inhibitor therapy and plan the best treatment.
PURPOSE: This clinical trial is studying cognitive function in older postmenopausal women with stage I, stage II, or stage III breast cancer receiving hormone therapy and in healthy volunteers.
详细描述
OBJECTIVES:
- Explore the impact of treatment with an aromatase inhibitor on the cognitive function of postmenopausal women with stage I-III breast cancer vs in cancer-free, age-matched healthy volunteers.
OUTLINE: Patients receive adjuvant anastrozole or letrozole in the absence of disease progression or unacceptable toxicity.
Patients and healthy volunteers undergo cognitive function testing consisting of neuropsychological battery tests and complete self-reported questionnaires (e.g., Squire Memory Self-Rating Questionnaire, and FACT-B Quality of Life Measure) regarding cognitive ability, quality of life, fatigue, and psychosocial status. Patients and healthy volunteers also undergo geriatric assessment at baseline and after 6 months of initiation with aromatase inhibitor therapy.
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
- 65 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Breast Cancer patients receiving aromatase treatment
干预措施: questionnaire administration (Other)
Breast Cancer patients receiving aromatase treatment
干预措施: anastrozole (Drug)
Breast Cancer patients receiving aromatase treatment
干预措施: letrozole (Drug)
Breast Cancer patients receiving aromatase treatment
干预措施: cognitive assessment (Procedure)
Breast Cancer patients receiving aromatase treatment
干预措施: psychosocial assessment and care (Procedure)
Healthy female controls age 60 and older
干预措施: questionnaire administration (Other)
Healthy female controls age 60 and older
干预措施: cognitive assessment (Procedure)
Healthy female controls age 60 and older
干预措施: psychosocial assessment and care (Procedure)
结局指标
主要结局
Impact of treatment with an aromatase inhibitor on cognitive function
时间窗: Prior to starting aromatase treatment and 6 months after starting the medication.
次要结局
未报告次要终点