Low Dose Aspirin Inhibition of COX-2 Derived PGE2 in Male Smokers
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Change in COX-2 dependent urinary PGE-M (ng/mg Cr) production after 16 days of aspirin treatment
研究概览
简要总结
Regular aspirin use has been associated with a reduction in the development of a number of different malignancies including lung cancer. The mechanism of aspirin's cancer prevention is not known. This study will evaluate whether once daily aspirin use can reduce the production of a protein named prostaglandin E2 (PGE-2), which is known to promote cancer. Specifically, this study will evaluate if aspirin can inhibit the production of PGE-2 by blocking an enzyme named cycloxygenase-2 (COX-2). To accomplish these goals, participants will take either aspirin 325 mg daily, celecoxib 200 mg twice daily, or the combination of both during various days of this 16-day study. Urine be collected to evaluate for PGE-2 production at 4 timepoints in this 16-day study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male gender
- •Current smoker of at least 10 cigarettes per day with history of ≥10 pack-years (py)
- •Former smoker, quit no more than 15 years ago with a history of at least 25 py
- •Ability to comply with the design of the study
- •Capacity to freeze urine sample at participant's residence if this participant desires to store the urine specimens in this manner
- •Baseline urine PGE-M > 13 ng/mg creatinine
- •Serum thromboxane > 150 μg/L
排除标准
- •History of aspirin use 1-14 days prior to screening
- •NSAID (ibuprofen, naprosyn, meloxicam, etc) use 1-7 days prior to screening
- •Inhaled glucocorticoid use 1-7 days prior to screening
- •Systemic glucocorticoid use 1-14 days prior to screening
- •History of peptic ulcer disease
- •Current or recent clinically significant bleeding
- •Allergy, intolerance or contraindication to aspirin or NSAID use
- •Thrombocytopenia (platelet count < 100,000) in 30 days prior to screening visit
- •Severe hepatic insufficiency
- •GFR < 30 mL/min/1.73 m2 in 30 days prior to screening visit
- •History of aspirin or celecoxib allergy
- •Elevated INR (>1.5) in 30 days prior to screening visit
- •Current diagnosis of malignancy or history of non-skin malignancy in last 5 years
- •Current use of systemic anticoagulants (e.g., warfarin (Coumadin), enoxaparin (Lovenox), Fondaparinux (Arixtra), dabigatran (Pradaxa))
- •Diagnosis of COPD
- •Intake of > 250 mg of fish oil supplementation daily
研究组 & 干预措施
Celecoxib, aspirin, followed by aspirin/celecoxib
Celecoxib 200 mg twice daily x3 days, aspirin 325 mg daily x10 days, celecoxib 200 mb twice daily + aspirin 325 mg daily x 3 days
干预措施: Aspirin 325 mg daily (Drug)
Celecoxib, aspirin, followed by aspirin/celecoxib
Celecoxib 200 mg twice daily x3 days, aspirin 325 mg daily x10 days, celecoxib 200 mb twice daily + aspirin 325 mg daily x 3 days
干预措施: Celecoxib 200 mg BID (Drug)
结局指标
主要结局
Change in COX-2 dependent urinary PGE-M (ng/mg Cr) production after 16 days of aspirin treatment
时间窗: 16 days
Baseline urinary PGE-2 metabolite (PGE-M) will be measured. Then after 3 days of COX-2 blockade with celecoxib, it will again be measured. Participants will then undergo 10 days of treatment with aspirin and urinary PGE-M will be measured. Finally, participants will be treated with combined aspirin and celecoxib for 3 days and urinary PGE-M will be measured one last time. Using these values, the degree of aspirin inhibition of COX-2 specific urinary PGE-M production can be calculated.
次要结局
未报告次要终点
研究者
Philip Lammers
Hematology/Oncology Clinical Fellow
Vanderbilt University