Pilot Trial to Evaluate Blood and Imaging Based Biomarkers for Aromatase Inhibitor Induced Musculoskeletal Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Oxylipin Levels
研究概览
简要总结
This is a pilot trial to evaluate for blood and imaging biomarkers in patients with breast cancer scheduled to start adjuvant hormonal therapy.
详细描述
This is a prospective single arm study enrolling patients (n = 25) with breast cancer scheduled to start adjuvant hormonal therapy. Patients would have completed all their primary treatments (surgery± radiation therapy) and are scheduled to start their adjuvant hormonal therapy. They get baseline blood drawn for oxylipins and sheer wave elastrography (SWE) ultrasound of their hands including wrists. They start adjuvant anastrozole and have blood drawn at 3mths and 6mths for measurement of oxylipins. SWE ultrasound is repeated at 6mths. This is a pilot trial to evaluate for blood and imaging biomarkers. Once pilot data is analyzed, goal is to apply for funding for a larger trial to further evaluate and validate these biomarkers
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Be capable of understanding the investigational nature of the study and all pertinent aspects of the study
- •Be capable of signing and providing written consent in accordance with institutional and federal guidelines
- •Have a histologically-confirmed diagnosis of breast cancer
- •Be willing and able to comply with scheduled visits, treatment plan, and SWE ultrasound imaging
- •Age ≥ 21 years
- •Post-menopausal women with 1st event of ER+ early stage breast cancer (0-3)
- •Completed definitive therapy (surgery ± radiation)
- •Candidates for adjuvant AI therapy
排除标准
- •Have received adjuvant or neo-adjuvant chemotherapy
- •Prior endocrine therapy (AI or tamoxifen)
- •History of rheumatoid arthritis or other autoimmune arthritis
- •Daily non-steroidal anti-inflammatory drug (NSAID) use (except for daily aspirin use)
- •Current use of daily corticosteroids or immunosuppressive therapies
结局指标
主要结局
Oxylipin Levels
时间窗: Baseline, Three months, and Six months
Change Oxylipin levels at Baseline, Three and Six Months
次要结局
- Tendon Stiffness(Baseline)
- Pain Levels(Baseline, Six months)