Back to resultsObstructive Sleep Apnea Syndrome After Oropharyngeal Cancer Treatment
Primary Purpose
Obstructive Sleep Apnea Syndrome, Oropharyngeal Cancer
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Surgery
Radio- chemotherapy
Sponsored by
About this trial
This is an interventional diagnostic trial for Obstructive Sleep Apnea Syndrome
Eligibility Criteria
Inclusion Criteria:
- Patient aged over 18 years old, male or female;
- Patient treated for a first oropharyngeal cancer located in upper airways (velum, side walls, back wall, base of tongue, vallecules), locally advanced, rated T3 or T4, whatever the stage N and M0;
- Patient who received curative treatment either surgical (excision and reconstruction free flap) with adjuvant radiotherapy or concurrent chemoradiotherapy;
- Treatment completed at least 12 months prior to study entry;
- Patient whose cancer disease is under control at exam time;
- Subject affiliated to a social security scheme;
- Subject agreeing to participate in the study and who signed the informed consent form.
Exclusion Criteria:
- Minor patient
- No affiliation to a social security scheme (beneficiary or assignee);
- Patient who did not signed the informed consent form
- Patient with neurological disease that can affect the upper airways function
- Patient has already been treated for head and neck cancer;
- Patient has a lesion classified T1 or T2 or M1;
- Patient has received different treatments: surgical resection without reconstruction, only radiotherapy
- Unweaned alcoholic patients
Sites / Locations
- Service d'ORL et de Chirurgie Cervico-Faciale - Hôpital de la Timone, AP-HM
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Treatment for oropharyngeal cancer by surgery
Treatment for oropharyngeal cancer by radio-chemotherapy
Arm Description
Disease-free patients treated for locally advanced oropharyngeal cancer for over 12 months by surgery
Disease-free patients treated for locally advanced oropharyngeal cancer for over 12 months by radio-chemotherapy
Outcomes
Primary Outcome Measures
Measuring the index of apneas and hypopneas (IAH), defined by the number of apneas per sleep hour
For an IAH <10: no Obstructive Sleep Apnea Syndrome (OSAS) For an IAH>30: severe OSAS is diagnosed
Secondary Outcome Measures
Full Information
NCT ID
NCT02881723
First Posted
August 24, 2016
Last Updated
August 24, 2016
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT02881723
Brief Title
Obstructive Sleep Apnea Syndrome After Oropharyngeal Cancer Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The level of knowledge about the consequences of oropharyngeal cancer treatment on sleep quality remains poor. Because of a high level of risk of developing an Obstructive Sleep Apnea Syndrome (OSAS), an accurate evaluation of the prevalence, of the risk factors and of the impact on quality of life is important in order to propose preventive and therapeutic solutions to these patients.
Detailed Description
Obstructive sleep apnea syndrome (OSAS) remains poorly documented in head and neck cancer cancer population, who have a higher risk than the general population. OSAS is a risk factor for quality of life impairment and cardiovascular morbidity and mortality.
This study proposes to carry out an OSAS prevalence study among a locally advanced head and neck cancer population, already treated and to compare the consequences of current therapeutic options in sleep quality.The primary research objective will be a prevalence determination in a locally advanced stages treated population of oropharyngeal cancer. Secondary objectives will be the comparison of the prevalence between the surgical group and the radio-chemotherapy group, the research of predictive factors of presenting an OSAS and the precision of the impact on quality of life.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea Syndrome, Oropharyngeal Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment for oropharyngeal cancer by surgery
Arm Type
Experimental
Arm Description
Disease-free patients treated for locally advanced oropharyngeal cancer for over 12 months by surgery
Arm Title
Treatment for oropharyngeal cancer by radio-chemotherapy
Arm Type
Experimental
Arm Description
Disease-free patients treated for locally advanced oropharyngeal cancer for over 12 months by radio-chemotherapy
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Type
Radiation
Intervention Name(s)
Radio- chemotherapy
Primary Outcome Measure Information:
Title
Measuring the index of apneas and hypopneas (IAH), defined by the number of apneas per sleep hour
Description
For an IAH <10: no Obstructive Sleep Apnea Syndrome (OSAS) For an IAH>30: severe OSAS is diagnosed
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient aged over 18 years old, male or female;
Patient treated for a first oropharyngeal cancer located in upper airways (velum, side walls, back wall, base of tongue, vallecules), locally advanced, rated T3 or T4, whatever the stage N and M0;
Patient who received curative treatment either surgical (excision and reconstruction free flap) with adjuvant radiotherapy or concurrent chemoradiotherapy;
Treatment completed at least 12 months prior to study entry;
Patient whose cancer disease is under control at exam time;
Subject affiliated to a social security scheme;
Subject agreeing to participate in the study and who signed the informed consent form.
Exclusion Criteria:
Minor patient
No affiliation to a social security scheme (beneficiary or assignee);
Patient who did not signed the informed consent form
Patient with neurological disease that can affect the upper airways function
Patient has already been treated for head and neck cancer;
Patient has a lesion classified T1 or T2 or M1;
Patient has received different treatments: surgical resection without reconstruction, only radiotherapy
Unweaned alcoholic patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine GEINDRE
Organizational Affiliation
Assistance Publique Hôpitaux de Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Service d'ORL et de Chirurgie Cervico-Faciale - Hôpital de la Timone, AP-HM
City
Marseille
ZIP/Postal Code
13005
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Obstructive Sleep Apnea Syndrome After Oropharyngeal Cancer Treatment
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