Early Diagnosis and Treatment of Sleep Disordered Breathing in Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- tumor perfusion
研究概览
简要总结
Sleep-disordered breathing at night is a common medical problem. It leads to daytime fatigue, impairment in concentration and daily activities, and a higher risk of cardiovascular disease and life-threatening events. A particularly common form is obstructive sleep apnea (OSA), and it is usually treatable with a high rate of patient satisfaction and improved quality of life using a continuous positive airway pressure (CPAP) device.
Treatment of this condition improves nighttime low-oxygen levels by ensuring patency of the upper airways. Research shows that in cancer, sleep disordered breathing is frequent. Low oxygen levels overnight may cause tumors to grow: tumors deprived of oxygen grow more blood vessels to try to get more oxygen, and growing more blood vessels makes the tumor grow. This study aims to examine how treating sleep-disordered breathing may lessen blood-flow to lung tumors, and thus serve to ultimately block tumor growth.
Participants of this study will undergo sleep study and receive CPAP therapy as a part of routine care.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Diagnosis of lung cancer in one of 2 sub-types:
- •newly diagnosed early-stage tumor
- •advanced-stage lung tumor undergoing serial contrast-CT imaging according to standard of care
- •Diagnosis of a metastatic carcinomatous mass in the lung
- •Positive study for sleep-disordered breathing (SDB) with intermittent hypoxia (IH) and clinical recommendation for CPAP
- •Ability and willingness to undergo baseline and repeat perfusion-CT imaging following 3- to 4 weeks of CPAP therapy for SDB (regardless of CPAP compliance).
- •Note: Participants will undergo sleep study and receive CPAP therapy as a part of routine care.
排除标准
- •Lung cancer with a negative sleep study (i.e., no SDB)
- •History of radio-contrast allergy
- •At excessive risk for contrast nephropathy (following standard radiology renal-risk criteria)
- •Pregnancy
结局指标
主要结局
tumor perfusion
时间窗: 3-4 weeks
maximum attenuation value (MAV) detected by perfusion-CT imaging
次要结局
- reduction in circulating tumor cells (CTC)(3-4 weeks)
- Reduction in tumor promoting micro RNA expression(3-4 weeks)
- Reduction in nocturnal hypoxia(3-4 weeks)
- Improvement in sleep quality(3-4 weeks)
- progression-free survival (PFS)(2 years)
- overall survival (OS)(2 years)
研究者
Mark M. Fuster, MD
Associate Professor of Medicine
University of California, San Diego