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Impact of Risk for OSA in Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04003961
Recruitment Status : Recruiting
First Posted : July 1, 2019
Last Update Posted : January 7, 2020
Sponsor:
Information provided by (Responsible Party):
Sezgi Şahin Duyar, Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

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.


Condition or disease Intervention/treatment
Obstructive Sleep Apnea Lung Cancer Other: STOP- BANG Questionnaire and Epworth sleepiness scale

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 160 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: The Impact of High Risk for OSA in Prognosis and Treatment Outcomes of Lung Cancer
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Group/Cohort Intervention/treatment
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.
Other: STOP- BANG Questionnaire and Epworth sleepiness scale
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.
Other: STOP- BANG Questionnaire and Epworth sleepiness scale
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.
Other: STOP- BANG Questionnaire and Epworth sleepiness scale
STOP- BANG Questionnaire and Epworth sleepiness scale will be filled in maximum 10 minutes




Primary Outcome Measures :
  1. STOP-BANG questionnaire [ Time Frame: 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 ) ]
    OSA - Low Risk : Yes to 0 - 2 questions OSA - Intermediate Risk : Yes to 3 - 4 questions OSA - High Risk : Yes to 5 - 8 questions or Yes to 2 or more of 4 STOP questions + male gender or Yes to 2 or more of 4 STOP questions + BMI > 35kg/m2 or Yes to 2 or more of 4 STOP questions + neck circumference 17 inches / 43cm in male or 16 inches / 41cm in female

  2. Epworth Sleepiness Scale (ESS) [ Time Frame: 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) ]
    Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions by which daytime sleepiness in eight different activities is assessed on a 4-point scale (0-3). The ESS score can range from 0 to 24. The higher the ESS score, the higher that person's 'daytime sleepiness'. ESS score ≥ 10 will be used to indicate excessive daytime sleepiness.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The patients will be selected from the palliative care outpatient clinic according to the overmentioned criteria
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04003961


Contacts
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Contact: Sezgi Şahin Duyar, MD 00905052975327 drsezgisahin@gmail.com

Locations
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Turkey
Atatürk Chest Diseases and Chest Surgery Training and Research Hospital Recruiting
Ankara, Turkey, 06280
Contact: Sezgi Şahin Duyar, MD    00905052975327    drsezgisahin@gmail.com   
Sponsors and Collaborators
Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
Investigators
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Study Director: Sezgi Şahin Duyar, MD Atatürk Chest Diseases and Thoracic Surgery Traininig and Research Hospital
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Responsible Party: Sezgi Şahin Duyar, Principal Investigator, Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
ClinicalTrials.gov Identifier: NCT04003961    
Other Study ID Numbers: 1905
First Posted: July 1, 2019    Key Record Dates
Last Update Posted: January 7, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sezgi Şahin Duyar, Atatürk Chest Diseases and Chest Surgery Training and Research Hospital:
Lung Cancer
Obstructive Sleep Apnea
Additional relevant MeSH terms:
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Lung Neoplasms
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Apnea
Respiration Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases