Obstructive Sleep Apnea Syndrome After Oropharyngeal Cancer Treatment

Not Applicable

• Conditions: Oropharyngeal Cancer; Obstructive Sleep Apnea Syndrome
• Interventions: Procedure: Surgery; Radiation: Radio- chemotherapy

• Registration Number: NCT02881723
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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.

Study Timeline

• Study Start: 2013-03
• Primary Completion: 2015-02
• Status Verified: 2016-08
• Study First Submitted: 2016-08-24
• Study First Submitted QC: 2016-08-24
• Last Update Submitted: 2016-08-24
• Study First Posted: 2016-08-29
• Last Update Posted: 2016-08-29
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment for oropharyngeal cancer by surgery	Surgery	Disease-free patients treated for locally advanced oropharyngeal cancer for over 12 months by surgery
Treatment for oropharyngeal cancer by radio-chemotherapy	Radio- chemotherapy	Disease-free patients treated for locally advanced oropharyngeal cancer for over 12 months by radio-chemotherapy

Primary Outcome Measures

Name	Time	Method
Measuring the index of apneas and hypopneas (IAH), defined by the number of apneas per sleep hour	1 day	For an IAH \<10: no Obstructive Sleep Apnea Syndrome (OSAS) For an IAH\>30: severe OSAS is diagnosed

Trial Locations

Locations (1)

Service d'ORL et de Chirurgie Cervico-Faciale - Hôpital de la Timone, AP-HM; 🇫🇷 Marseille, France