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Study stopped due to lack of enrollment.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPAP therapy | CPAP therapy (minimum of 3-4 weeks) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPAP | Device | CPAP therapy 3-4 weeks |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| tumor perfusion | maximum attenuation value (MAV) detected by perfusion-CT imaging | 3-4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| reduction in circulating tumor cells (CTC) | 3-4 weeks | |
| Reduction in tumor promoting micro RNA expression | 3-4 weeks | |
| Reduction in nocturnal hypoxia |
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Inclusion Criteria:
Diagnosis of lung cancer in one of 2 sub-types:
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.
Exclusion Criteria:
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Community sample
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| Name | Affiliation | Role |
|---|---|---|
| Mark Fuster, MD | Universityof California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC San Diego Moores Cancer Center | La Jolla | California | 92093 | United States |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D055752 | Small Cell Lung Carcinoma |
| D012891 | Sleep Apnea Syndromes |
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
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| 3-4 weeks |
| Improvement in sleep quality | 3-4 weeks |
| progression-free survival (PFS) | 2 years |
| overall survival (OS) | 2 years |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D012138 |
| Respiratory Therapy |