Clinical trial NCT03443908: Early Diagnosis and Treatment of Sleep Disordered Breathing in Lung Cancer
Official title: Early Diagnosis and Treatment of Sleep Disordered Breathing in Lung Cancer
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Lung Cancer
Keywords: lung cancer
non small cell lung cancer
nsclc
small cell lung cancer
sclc
metastic lung mass
sleep disordered breathing
sdb
obstructive sleep apnea
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2018-02-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample

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.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of lung cancer in one of 2 sub-types:

  1. newly diagnosed early-stage tumor
  2. 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

Primary outcomes:
measure: tumor perfusion
timeFrame: 3-4 weeks
Secondary outcomes:
measure: reduction in circulating tumor cells (CTC)
timeFrame: 3-4 weeks
measure: Reduction in tumor promoting micro RNA expression
timeFrame: 3-4 weeks
measure: Reduction in nocturnal hypoxia
timeFrame: 3-4 weeks
measure: Improvement in sleep quality
timeFrame: 3-4 weeks
measure: progression-free survival (PFS)
timeFrame: 2 years
measure: overall survival (OS)
timeFrame: 2 years
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UC San Diego Moores Cancer Center
state: California
Study officials:
affiliation: Universityof California, San Diego
name: Mark Fuster, MD
role: PRINCIPAL_INVESTIGATOR
References: