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Early Diagnosis and Treatment of Sleep Disordered Breathing in Lung Cancer
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.
| Condition or disease | Intervention/treatment |
|---|---|
| Lung Cancer | Device: CPAP |
| Study Type : | Observational |
| Estimated Enrollment : | 20 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Official Title: | Early Diagnosis and Treatment of Sleep Disordered Breathing in Lung Cancer |
| Actual Study Start Date : | November 17, 2017 |
| Estimated Primary Completion Date : | November 17, 2020 |
| Estimated Study Completion Date : | November 17, 2021 |
| Group/Cohort | Intervention/treatment |
|---|---|
|
CPAP therapy
CPAP therapy (minimum of 3-4 weeks)
|
Device: CPAP
CPAP therapy 3-4 weeks
Other Name: continuous positive airway pressure
|
- tumor perfusion [ Time Frame: 3-4 weeks ]maximum attenuation value (MAV) detected by perfusion-CT imaging
- reduction in circulating tumor cells (CTC) [ Time Frame: 3-4 weeks ]
- Reduction in tumor promoting micro RNA expression [ Time Frame: 3-4 weeks ]
- Reduction in nocturnal hypoxia [ Time Frame: 3-4 weeks ]
- Improvement in sleep quality [ Time Frame: 3-4 weeks ]
- progression-free survival (PFS) [ Time Frame: 2 years ]
- overall survival (OS) [ Time Frame: 2 years ]
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
-
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.
Exclusion Criteria:
- 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
| Contact: Mark Fuster, MD | 858-552-8585 ext 7349 | mfuster@ucsd.edu |
| United States, California | |
| UC San Diego Moores Cancer Center | Recruiting |
| La Jolla, California, United States, 92093 | |
| Contact: Mark Fuster, MD | |
| Principal Investigator: | Mark Fuster, MD | Universityof California, San Diego |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date | February 1, 2018 | ||||||
| First Posted Date | February 23, 2018 | ||||||
| Last Update Posted Date | March 1, 2019 | ||||||
| Actual Study Start Date | November 17, 2017 | ||||||
| Estimated Primary Completion Date | November 17, 2020 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures |
tumor perfusion [ Time Frame: 3-4 weeks ] maximum attenuation value (MAV) detected by perfusion-CT imaging
|
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| Original Primary Outcome Measures | Same as current | ||||||
| Change History | |||||||
| Current Secondary Outcome Measures |
|
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| Original Secondary Outcome Measures | Same as current | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title | Early Diagnosis and Treatment of Sleep Disordered Breathing in Lung Cancer | ||||||
| Official Title | Early Diagnosis and Treatment of Sleep Disordered Breathing in Lung Cancer | ||||||
| Brief Summary |
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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| Detailed Description | Not Provided | ||||||
| Study Type | Observational | ||||||
| Study Design | Observational Model: Case-Only Time Perspective: Prospective |
||||||
| Target Follow-Up Duration | Not Provided | ||||||
| Biospecimen | Not Provided | ||||||
| Sampling Method | Non-Probability Sample | ||||||
| Study Population | Community sample | ||||||
| Condition | Lung Cancer | ||||||
| Intervention | Device: CPAP
CPAP therapy 3-4 weeks
Other Name: continuous positive airway pressure
|
||||||
| Study Groups/Cohorts | CPAP therapy
CPAP therapy (minimum of 3-4 weeks)
Intervention: Device: CPAP
|
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| Publications * | Not Provided | ||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status | Recruiting | ||||||
| Estimated Enrollment |
20 | ||||||
| Original Estimated Enrollment | Same as current | ||||||
| Estimated Study Completion Date | November 17, 2021 | ||||||
| Estimated Primary Completion Date | November 17, 2020 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria |
Inclusion Criteria:
Note: Participants will undergo sleep study and receive CPAP therapy as a part of routine care. Exclusion Criteria:
|
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| Sex/Gender |
|
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers | No | ||||||
| Contacts |
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| Listed Location Countries | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number | NCT03443908 | ||||||
| Other Study ID Numbers | 161552 | ||||||
| Has Data Monitoring Committee | Not Provided | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Mark M. Fuster, MD, University of California, San Diego | ||||||
| Study Sponsor | Mark M. Fuster, MD | ||||||
| Collaborators | Not Provided | ||||||
| Investigators |
|
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| PRS Account | University of California, San Diego | ||||||
| Verification Date | February 2019 | ||||||
