Clinical trial NCT04003961: Impact of Risk for OSA in Lung Cancer
Official title: The Impact of High Risk for OSA in Prognosis and Treatment Outcomes of Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Lung Cancer
Keywords: Lung Cancer
Obstructive Sleep Apnea
Lead sponsor: Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-07-01
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients will be selected from the palliative care outpatient clinic according to the overmentioned criteria

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.

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

Primary outcomes:
measure: STOP-BANG questionnaire
timeFrame: Up to 4 months from the initial diagnosis of lung cancer (the patients who has not initiated or has not finished the first line therapy )
measure: Epworth Sleepiness Scale (ESS)
timeFrame: Up to 4 months from the initial diagnosis of lung cancer (the patients who has not initiated or has not finished the first line therapy will be assessed with Epworth Sleepiness Scale)
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
Study officials:
affiliation: Atatürk Chest Diseases and Thoracic Surgery Traininig and Research Hospital
name: Sezgi Şahin Duyar, MD
role: STUDY_DIRECTOR
References: