Early Diagnosis and Treatment of Sleep Disordered Breathing in Lung Cancer

NCT03443908 | Withdrawn FDA Device

• 1 other identifier: 161552
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• tumor perfusion

  maximum attenuation value (MAV) detected by perfusion-CT imaging

  3-4 weeks

Secondary Outcomes (6)

• reduction in circulating tumor cells (CTC)

  3-4 weeks

• Reduction in tumor promoting micro RNA expression

  3-4 weeks

• Reduction in nocturnal hypoxia

  3-4 weeks

• Improvement in sleep quality

  3-4 weeks

• progression-free survival (PFS)

  2 years

Study Arms (1)

CPAP therapy

CPAP therapy (minimum of 3-4 weeks)

Device: CPAP

Interventions

CPAP DEVICE

CPAP therapy 3-4 weeks

Also known as: continuous positive airway pressure

CPAP therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community sample

You may qualify if:

• Diagnosis of lung cancer in one of 2 sub-types:
• newly diagnosed early-stage tumor
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mark M. Fuster, MD: lead

Study Sites (1)

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma; Sleep Apnea Syndromes; Sleep Apnea, Obstructive

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Mark Fuster, MD

  Universityof California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: February 1, 2018
• First Posted: February 23, 2018
• Study Start: November 17, 2017
• Primary Completion: May 13, 2019
• Study Completion: May 13, 2019
• Last Updated: December 17, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)