Overview

This trial is active, not recruiting.

Conditions obstructive sleep apnea syndrome, oropharyngeal cancer
Treatments surgery, radio- chemotherapy
Sponsor Assistance Publique Hopitaux De Marseille
Start date March 2013
End date February 2015
Trial size 51 participants
Trial identifier NCT02881723, 2012-25, 2012-A00863-40

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
Disease-free patients treated for locally advanced oropharyngeal cancer for over 12 months by surgery
surgery
(Experimental)
Disease-free patients treated for locally advanced oropharyngeal cancer for over 12 months by radio-chemotherapy
radio- chemotherapy

Primary Outcomes

Measure
Measuring the index of apneas and hypopneas (IAH), defined by the number of apneas per sleep hour
time frame: 1 day

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Assistance Publique Hopitaux De Marseille.