Impact of Risk for OSA in Lung Cancer

NCT ID: NCT04003961

Last Updated: 2022-01-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 160 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2021-12-31

Brief Summary

Background: Previous studies have reported that intermittent hypoxia in obstructive sleep apnea (OSA) is associated with tumor progression, metastasis and treatment outcomes. However, studies explaining the relationships between specific types of cancer and OSA are needed. In this study, it is aimed to show the effect of excessive daytime sleepiness as determined by Epworth sleepiness scale(ESS) and the effect of OSA risk determined by STOP BANG questionnaire on survival and treatment outcomes in lung cancer.

Method: The patients who admit the palliative care outpatient clinic of our hospital with the diagnosis of lung cancer (stage 3 and stage 4 non-small cell lung cancer or limited / extensive stage small cell lung cancer) between July 2019-2020 will be assessed for excessive daytime sleepiness(EDS) and risk of obstructive sleep apnea (OSA) by Epworth sleepiness scale and the STOP-BANG questionnaire. The patients will be grouped according to the risk of OSA and EDS.Total / progression-free survival, treatment outcomes and side effects of the treatment will be evaluated comparatively.

Detailed Description

The patients who admit the palliative care outpatient clinic of our hospital with the diagnosis of lung cancer (stage 3 and stage 4 non-small cell lung cancer or limited / extensive stage small cell lung cancer) between July 2019-2020 prior to the treatment and the patient who has not yet completed the first-line chemotherapy with a weight loss <10% will be invited to fill the Epworth sleepiness scale and the STOP-BANG questionnaire. Patients' anthropometric measurements (height, weight, BMI, fat-free BMI, neck circumference) will be taken. The treatment outcomes and side-effects in patients with EDS and moderate / high risk for OSA will be compared with patients with low OSA risk. Demographic information (age, gender, smoking history), anthropometric measurements (height, weight, body mass index, fat free body mass index, neck circumference), clinical information (snoring, witnessed apnea, daytime excessive sleep presence of symptoms of symptoms, pulmonary function tests, radiological TNM stages, diagnostic method, diagnosis date, fiberoptic bronchoscopy findings, ECOG performance status, treatment results, treatment-related side effects) laboratory values (complete blood count results albumin, lactate dehydrogenase level) and the results of Epworth sleepiness scale and of STOP-BANG questionnaire will be recorded.

Conditions

Obstructive Sleep Apnea; Lung Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Moderate/high risk for OSA with EDS

All clinical data of the patients who has moderate/high risk for OSA with excessive daytime sleepiness (EDS) will be assessed with statistical methods.

STOP- BANG Questionnaire and Epworth sleepiness scale

Intervention Type: OTHER

STOP- BANG Questionnaire and Epworth sleepiness scale will be filled in maximum 10 minutes

Moderate/high risk for OSA without EDS

All clinical data of the patients who has moderate/high risk for OSA without excessive daytime sleepiness(EDS) will be assessed with statistical methods.

STOP- BANG Questionnaire and Epworth sleepiness scale

Intervention Type: OTHER

STOP- BANG Questionnaire and Epworth sleepiness scale will be filled in maximum 10 minutes

Low risk for OSA

All clinical data of the patients who has low risk for OSA will be assessed with statistical methods.

STOP- BANG Questionnaire and Epworth sleepiness scale

Intervention Type: OTHER

STOP- BANG Questionnaire and Epworth sleepiness scale will be filled in maximum 10 minutes

Interventions

STOP- BANG Questionnaire and Epworth sleepiness scale

STOP- BANG Questionnaire and Epworth sleepiness scale will be filled in maximum 10 minutes

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients between 18-75 years of age with the diagnosis of lung cancer (stage 3 and 4 non-small cell lung cancer or limited / extensive small cell lung cancer) and who sign the informed consent to participate in the study

Exclusion Criteria

• Patients older than 75 years old amd younger than 18 years old
• Sedatives / anxiolytic drug users
• Neurological or psychiatric disorders
• Those who have contradictions for standard chemoradiotherapy (ECOG performance status 3-4)
• Stage 1 or stage 2 non-small cell lung cancer patients who may be referred to thoracic surgery
• Patients with brain metastasis
• People who have a shift work
• Vena cava superior syndrome
• Alcohol dependence
• Malignant airway stenosis
• Congestive heart failure (EF <50%)
• Patients with chronic renal failure

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sezgi Şahin Duyar

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sezgi Şahin Duyar, MD

Role: STUDY_DIRECTOR

Atatürk Chest Diseases and Thoracic Surgery Traininig and Research Hospital

Locations

Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

1905

Identifier Type: -

Identifier Source: org_study_id