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Early Diagnosis and Treatment of Sleep Disordered Breathing in Lung Cancer

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ClinicalTrials.gov Identifier: NCT03443908
Recruitment Status : Recruiting
First Posted : February 23, 2018
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Mark M. Fuster, MD, University of California, San Diego

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.


Condition or disease Intervention/treatment
Lung Cancer Device: CPAP

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

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




Primary Outcome Measures :
  1. tumor perfusion [ Time Frame: 3-4 weeks ]
    maximum attenuation value (MAV) detected by perfusion-CT imaging


Secondary Outcome Measures :
  1. reduction in circulating tumor cells (CTC) [ Time Frame: 3-4 weeks ]
  2. Reduction in tumor promoting micro RNA expression [ Time Frame: 3-4 weeks ]
  3. Reduction in nocturnal hypoxia [ Time Frame: 3-4 weeks ]
  4. Improvement in sleep quality [ Time Frame: 3-4 weeks ]
  5. progression-free survival (PFS) [ Time Frame: 2 years ]
  6. overall survival (OS) [ Time Frame: 2 years ]


Information from the National Library of Medicine

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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
Study Population
Community sample
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03443908


Contacts
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Contact: Mark Fuster, MD 858-552-8585 ext 7349 mfuster@ucsd.edu

Locations
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United States, California
UC San Diego Moores Cancer Center Recruiting
La Jolla, California, United States, 92093
Contact: Mark Fuster, MD         
Sponsors and Collaborators
Mark M. Fuster, MD
Investigators
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Principal Investigator: Mark Fuster, MD Universityof California, San Diego

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Responsible Party: Mark M. Fuster, MD, Associate Professor of Medicine, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03443908     History of Changes
Other Study ID Numbers: 161552
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Mark M. Fuster, MD, University of California, San Diego:
lung cancer
non small cell lung cancer
nsclc
small cell lung cancer
sclc
metastic lung mass
sleep disordered breathing
sdb
obstructive sleep apnea

Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Aspiration
Sleep Apnea Syndromes
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Pathologic Processes
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases