A Case Control Study to Define Clinical, Immunologic and Radiographic Features of the Aromatase Inhibitor Arthralgia Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Difference in DAS-28 between cases and controls
研究概览
简要总结
The CIRAS study will investigate postmenopausal breast cancer patients with hand pain and compare those receiving aromatase inhibitors (cases) to breast cancer patients with hand pain not receiving aromatase inhibitors (controls) in order assess whether this syndrome is an inflammatory arthritis.
详细描述
This study is for women with post-menopausal breast cancer and hand pain. Patients do not need to be taking aromatase inhibitors to be eligible for the study. We want to study the joint findings in patients with hand pain and breast cancer undergoing treatment with aromatase inhibitor medications and compare them to patients with hand pain and breast cancer not treated with these medications.
Aromatase inhibitor drugs are used in certain types of breast cancer to reduce the risk of cancer returning after treatment. One of the side effects of aromatase inhibitors is the development of joint pain, a complication known as the Arthralgia Syndrome. The cause of the Arthralgia Syndrome is not known, but we suspect that the pain may be due to inflammation in the joints. Currently, the only effective treatment is to stop the aromatase inhibitor, and so affected patients may miss out on an otherwise useful treatment to prevent return of their cancer.
Post-menopausal patients with breast cancer and hand pain can enroll in the study. Patients will be asked to come for a separate visit which will take about half a day.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
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
- •Postmenopausal women aged over 18 with stage I-III breast cancer undergoing treatment at the Lombardi Cancer Center.
- •Presence of hand pain
- •No active signs of ongoing malignant disease
排除标准
- •Known autoimmune disease for example, rheumatoid arthritis, systemic lupus erythematosis, polymyalgia rheumatica, or seronegative arthritis.
- •Unable to complete informed consent process
结局指标
主要结局
Difference in DAS-28 between cases and controls
时间窗: 1 year
次要结局
- Differences between cases and controls in mean ESR, TNF-alpha, IL-6 and ultrasound measurement of tenosynovitis.(1 year)
研究者
Victoria Shanmugam
Associate Professor of Medicine
George Washington University