Longitudinal Assessment of Arthralgia and Related Symptoms in Breast Cancer Patients Receiving Aromatase Inhibitors
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Incidence, onset and severity of arthralgia during anastrozole treatment
研究概览
简要总结
The goal of this research study is to learn more about what it is like for patients with breast cancer to receive treatment with the drug anastrozole. Researchers want to learn about possible symptoms, such as joint pain, that patients may experience during treatment. Researchers also want to learn more about which patients are most likely to have joint symptoms by looking at certain proteins from routine blood draw samples.
详细描述
Study Groups:
If you agree to take part in this study, you will be assigned to one of two groups, depending on how long you have been receiving anastrozole treatment. If you are within two months prior to or one month after starting treatment, you will be assigned to Group 1 and you will be followed through 2 years of treatment. If you have been taking anastrozole for about 2 years, you will be assigned to Group 2 and you will be followed through your third year of treatment.
Study Procedures:
You will complete tests and procedures during your regularly scheduled clinic visits.
Assessment 1:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with early stage hormone receptor positive breast cancer who are at these 2 time points in their anastrozole treatment: 1) at the time period between two months prior or one month after beginning of their anastrozole treatment (Cohort 1); 2) patients within +/- 2 months of the beginning of the third year of anastrozole treatment (Cohort 2).
- •Patients >= 18 years old.
排除标准
- •Patients with metastatic disease.
- •Patients who cannot complete the assessment tools.
- •Patients without telephone access.
结局指标
主要结局
Incidence, onset and severity of arthralgia during anastrozole treatment
时间窗: 3 Years
次要结局
未报告次要终点