Early Diagnosis and Treatment of Sleep Disordered Breathing in Lung Cancer

December 2, 2021 updated by: Mark M. Fuster, MD

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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92093
        • UC San Diego Moores Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Community sample

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CPAP therapy
CPAP therapy (minimum of 3-4 weeks)
Device: CPAP
CPAP therapy 3-4 weeks
Other Names:
  • continuous positive airway pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tumor perfusion
Time Frame: 3-4 weeks
maximum attenuation value (MAV) detected by perfusion-CT imaging
3-4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
reduction in circulating tumor cells (CTC)
Time Frame: 3-4 weeks
3-4 weeks
Reduction in tumor promoting micro RNA expression
Time Frame: 3-4 weeks
3-4 weeks
Reduction in nocturnal hypoxia
Time Frame: 3-4 weeks
3-4 weeks
Improvement in sleep quality
Time Frame: 3-4 weeks
3-4 weeks
progression-free survival (PFS)
Time Frame: 2 years
2 years
overall survival (OS)
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mark M. Fuster, MD

Investigators

  • Principal Investigator: Mark Fuster, MD, Universityof California, San Diego

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 17, 2017

Primary Completion (Actual)

May 13, 2019

Study Completion (Actual)

May 13, 2019

Study Registration Dates

First Submitted

February 1, 2018

First Submitted That Met QC Criteria

February 21, 2018

First Posted (Actual)

February 23, 2018

Study Record Updates

Last Update Posted (Actual)

December 17, 2021

Last Update Submitted That Met QC Criteria

December 2, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 161552

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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