Early Diagnosis and Treatment of Sleep Disordered Breathing in Lung Cancer

Lung Cancer Clinical Trial

Official title:

Early Diagnosis and Treatment of Sleep Disordered Breathing in Lung Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03443908
• Other study ID #: 161552
• Status: Withdrawn
• Start date: November 17, 2017
• Est. completion date: May 13, 2019

Study information

• Verified date: December 2021
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 13, 2019
• Est. primary completion date: May 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Respiratory Aspiration
• Sleep Apnea Syndromes

Intervention

Device:
• CPAP
CPAP therapy 3-4 weeks

Locations

Country	Name	City	State
United States	UC San Diego Moores Cancer Center	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
Mark M. Fuster, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tumor perfusion	maximum attenuation value (MAV) detected by perfusion-CT imaging	3-4 weeks
Secondary	reduction in circulating tumor cells (CTC)		3-4 weeks
Secondary	Reduction in tumor promoting micro RNA expression		3-4 weeks
Secondary	Reduction in nocturnal hypoxia		3-4 weeks
Secondary	Improvement in sleep quality		3-4 weeks
Secondary	progression-free survival (PFS)		2 years
Secondary	overall survival (OS)		2 years