Early Diagnosis and Treatment of Sleep Disordered Breathing in Lung Cancer

Withdrawn

• Conditions: Lung Cancer
• Interventions: Device: CPAP

• Registration Number: NCT03443908
• Lead Sponsor: Mark M. Fuster, MD

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-17
• Study First Submitted: 2018-02-01
• Study First Submitted QC: 2018-02-21
• Study First Posted: 2018-02-23
• Primary Completion: 2019-05-13
• Study Completion: 2019-05-13
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-02
• Last Update Posted: 2021-12-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CPAP therapy	CPAP	CPAP therapy (minimum of 3-4 weeks)

Primary Outcome Measures

Name	Time	Method
tumor perfusion	3-4 weeks	maximum attenuation value (MAV) detected by perfusion-CT imaging

Secondary Outcome Measures

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

Trial Locations

Locations (1)

UC San Diego Moores Cancer Center; 🇺🇸 La Jolla, California, United States