Pioglitazone for Lung Cancer Chemoprevention
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- 6-month Histology Score
研究概览
简要总结
This is a chemoprevention trial evaluating the diabetic agent pioglitazone. Non-diabetic subjects at risk for lung cancer (based on smoking history, lung function testing, and atypical cells in a sputum sample) receive either placebo or pioglitazone and have chest computerized tomography (CAT) scans and examinations of their airways with a bronchoscope at the start of the trial and after 6 months on treatment. Compensation will be provided to the subject after completing the trial.
详细描述
This trial evaluates the oral peroxisome proliferator-activated receptor gamma (PPARgamma) agonist pioglitazone in a double-blind placebo controlled trial. The high risk current and former smokers qualify based on tobacco exposure, airflow limitation on lung function testing, and sputum cytologic atypia. Subjects have a quantitative high resolution thoracic CT scan and a fluorescent bronchoscopy at study entry and after 6 months on drug or placebo. Biologic samples are collected at both time points. The primary outcome is endobronchial histology and determining if pioglitazone can retard progression. Secondary endpoints related to the PPAR gamma signaling pathway will also be analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current or former smoker (at least 10 pack years);
- •One or more of the following:
- •Mild or worse sputum atypia
- •Airflow Limitation (FEV1/FVC<70% predicted)
- •Biopsy proven airway dysplasia
排除标准
- •myocardial infarction (MI) with ejection fraction < 50%;
- •severe/unstable angina;
- •history of coronary or peripheral arterial bypass grafting;
- •New York Heart Association (NYHA) class III or IV congestive heart failure;
- •hypoxemia (less than POX 90 with supplemental oxygen); Diabetes type I or II; severe COPD (GOLD stage III or IV); clinically significant edema requiring diuretic therapy;
- •life expectancy < 6 months; history of bladder cancer
- •pregnant or breast feeding; inability to give informed consent
研究组 & 干预措施
Arm 1: pioglitazone
Current or former smokers receive 6 months of treatment with pioglitazone
干预措施: fluorescence bronchoscopy (Procedure)
Arm 1: pioglitazone
Current or former smokers receive 6 months of treatment with pioglitazone
干预措施: quantitative high resolution CT scan (Procedure)
Arm 1: pioglitazone
Current or former smokers receive 6 months of treatment with pioglitazone
干预措施: PIOGLITAZONE VS. PLACEBO 30 mg (Drug)
Arm 2: placebo
Current or former smokers receive 6 months of treatment with placebo
干预措施: fluorescence bronchoscopy (Procedure)
Arm 2: placebo
Current or former smokers receive 6 months of treatment with placebo
干预措施: quantitative high resolution CT scan (Procedure)
结局指标
主要结局
6-month Histology Score
时间窗: 6 months
Biopsies were classified into one of the following 8 World Health Organization defined categories to classify the endobronchial lesion and assign a score according to the following scale: 1 = normal bronchial epithelium; 2 = reserve cell hyperplasia; 3 = squamous metaplasia without atypia; 4 = mild dysplasia; 5 = moderate dysplasia; 6 = severe dysplasia; 7 = carcinoma in situ (CIS); and 8 = invasive carcinoma. 1 represents the best outcome and 8 represents the worst outcome.
次要结局
未报告次要终点