Lung CancerNCT03443908
Early Diagnosis and Treatment of Sleep Disordered Breathing in Lung Cancer
An observational study of Lung Cancer, run by Mark M. Fuster, MD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- CPAP
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2017to 13 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Community sample
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UC San Diego Moores Cancer Center
La Jolla, California, 92093
About this study
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.
- Conditions
- Lung Cancer
- Being tested
- CPAP
- Keywords
- lung cancer, non small cell lung cancer, nsclc, small cell lung cancer, sclc, metastic lung mass, sleep disordered breathing, sdb, obstructive sleep apnea
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Sleep Apnea Syndromes, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPDevice
Also called continuous positive airway pressure
CPAP therapy 3-4 weeks
| Study group | Role | What they receive |
|---|---|---|
| CPAP therapy | CPAP therapy (minimum of 3-4 weeks) Receives: Device: CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
tumor perfusion
maximum attenuation value (MAV) detected by perfusion-CT imaging
Measured: 3-4 weeks
Secondary outcomes (6)
reduction in circulating tumor cells (CTC)
Measured: 3-4 weeks
Reduction in tumor promoting micro RNA expression
Measured: 3-4 weeks
Reduction in nocturnal hypoxia
Measured: 3-4 weeks
Improvement in sleep quality
Measured: 3-4 weeks
progression-free survival (PFS)
Measured: 2 years
overall survival (OS)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start17 Nov 2017
- Primary completion13 May 2019
- Study completion13 May 2019
Why it stopped: Study stopped due to lack of enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mark M. Fuster, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mark M. Fuster, MD, University of California, San Diego
- Investigators
- Mark Fuster, MD, Principal investigator, Universityof California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03443908
- Sponsor's protocol ID
- 161552
- Status last verified
- Dec 2021
- First submitted
- 1 Feb 2018
- Last updated
- 17 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Diagnosis and Treatment of Sleep Disordered Breathing in Lung Cancer
- ClinicalTrials.gov ID
- NCT03443908
- Acronym / sponsor ID
- 161552
- Conditions
- Lung Cancer
- Keywords
- lung cancer, non small cell lung cancer, nsclc, small cell lung cancer, sclc, metastic lung mass, sleep disordered breathing, sdb
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study stopped due to lack of enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mark M. Fuster, MDUniversity, hospital or other
- Study start
- 17 Nov 2017 (actual)
- Primary completion
- 13 May 2019 (actual)
- Study completion
- 13 May 2019 (actual)
- First posted
- 23 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CPAP therapy | – | Device: CPAPCPAP therapy (minimum of 3-4 weeks) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAPAlso: continuous positive airway pressureCPAP therapy 3-4 weeks | Device | CPAP therapy |
Primary outcome
tumor perfusion
Time frame: 3-4 weeks
maximum attenuation value (MAV) detected by perfusion-CT imaging
6 secondary outcomes
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Fuster, MD principal investigator
Universityof California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Mark M. Fuster, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tumor perfusion (time frame: 3-4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2021.