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 |
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 |
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
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Turkey | |
Atatürk Chest Diseases and Chest Surgery Training and Research Hospital | |
Ankara, Turkey, 06280 |
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 |
|
||||
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 |
|
||||
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 |
|
||||
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 |
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:
Exclusion Criteria:
|
||||
Sex/Gender |
|
||||
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 |
|
||||
IPD Sharing Statement |
|
||||
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 |
|
||||
PRS Account | Atatürk Chest Diseases and Chest Surgery Training and Research Hospital | ||||
Verification Date | January 2021 |