4006-776-356 出国就医服务电话

免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Impact of Risk for OSA in Lung Cancer

Impact of Risk for OSA in Lung Cancer

Study Description
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.
Study Design
Layout table for study information
Study Type : Observational [Patient Registry]
Actual 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
Actual Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
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

Outcome Measures
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.


Eligibility Criteria
Layout table for eligibility information
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
Contacts and Locations

Locations
Layout table for location information
Turkey
Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
Ankara, Turkey, 06280
Sponsors and Collaborators
Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
Investigators
Layout table for investigator information
Study Director: Sezgi Şahin Duyar, MD Atatürk Chest Diseases and Thoracic Surgery Traininig and Research Hospital
Tracking Information
First Submitted Date June 21, 2019
First Posted Date July 1, 2019
Last Update Posted Date January 13, 2021
Actual Study Start Date July 1, 2019
Actual Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 28, 2019)
  • 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
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration 12 Months
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The patients will be selected from the palliative care outpatient clinic according to the overmentioned criteria
Condition
  • Obstructive Sleep Apnea
  • Lung Cancer
Intervention Other: STOP- BANG Questionnaire and Epworth sleepiness scale
STOP- BANG Questionnaire and Epworth sleepiness scale will be filled in maximum 10 minutes
Study Groups/Cohorts
  • 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.
    Intervention: Other: STOP- BANG Questionnaire and Epworth sleepiness scale
  • 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.
    Intervention: Other: STOP- BANG Questionnaire and Epworth sleepiness scale
  • Low risk for OSA
    All clinical data of the patients who has low risk for OSA will be assessed with statistical methods.
    Intervention: Other: STOP- BANG Questionnaire and Epworth sleepiness scale
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: June 28, 2019)
160
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2021
Actual Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT04003961
Other Study ID Numbers 1905
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Sezgi Şahin Duyar, Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
Study Sponsor Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
Collaborators Not Provided
Investigators
Study Director: Sezgi Şahin Duyar, MD Atatürk Chest Diseases and Thoracic Surgery Traininig and Research Hospital
PRS Account Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
Verification Date January 2021

治疗医院