NCT01080170已完成不适用
The Effect of Aromatase Inhibitors on Cardiovascular Risk Factors in Women With Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Body Composition
研究概览
简要总结
This study explores how aromatase inhibitor therapy affects risk factors for heart disease in postmenopausal women with breast cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Ambulatory women (aged 60-75), with a new diagnosis of nonmetastatic, hormone-receptor positive breast cancer, having undergone lumpectomy. They will not need chemotherapy and will have been prescribed but not yet started anastrazole. All will need a course of radiation therapy as part of usual care. Participants are instructed not to change their physical activity or eating habits over the period of the study.
- •Comparisons are:
- •Identical to the cases except they are hormone-receptor negative and don't need hormonal therapy.
- •Healthy controls.
排除标准
- •Nicotine usage
- •Metastatic breast cancer
- •Need for chemotherapy
- •AI other than anastrazole
- •Usage of steroids (equivalent of equal then or more than 7.5 mg prednisone x 3 months)
- •Clinically significant abnormality of thyroid function
- •Treatment with gonadal hormone replacement therapy within last 3 years
- •Status post unilateral/bilateral surgical oophorectomy
- •Having experienced a medical event, which may confound study outcomes [e.g. heart attack, stroke, cancer (metastatic or newly diagnosed within last 5 years, except for non-melanoma skin cancer and breast), lupus, rheumatoid arthritis, chronic inflammatory disease]
- •Medication-dependent diabetes mellitus or hypercholesterolemia.
- •Gastric surgery
- •Weight loss medication (prescription or over the counter)
结局指标
主要结局
Body Composition
时间窗: 12 months
次要结局
- Lipids(12 months)
研究者
Van Londen, Gijsberta
PI
University of Pittsburgh
研究点 (1)
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