Prevalence of Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) Following Squamous Cell Carcinomas of the Oropharynx Treatment by Combined Chemoradiotherapy

Oropharyngeal Cancer Clinical Trial

— COROSAS  

Official title:

Prevalence of Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) Following Squamous Cell Carcinomas of the Oropharynx Treatment by Combined Chemoradiotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04440618
• Other study ID #: COROSAS
• Status: Recruiting
• Start date: July 30, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: January 2021
• Source: Poitiers University Hospital
• Contact: Xavier DUFOUR, Pr
• Phone: 05 49 44 33 89
• Email: xavier.dufour[@]chu-poitiers.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study's aim is to determinate the prevalence of obstructive sleep apnea hypopnea syndrome after treatment by combined chemoradiotherapy in a locally advanced stages treated population of oropharyngeal cancer. Indeed, the level of knowledge about the consequences of oropharyngeal cancer treatment on sleep quality remains poor but the few studies published on the subject suggest an increased risk of development of OSAHS for these patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age> 18 years old
• Performance Status 0-2
• Squamous cell carcinoma of the oropharynx treated with concomitant chemoradiotherapy
• Treatment termination time greater than 6 months at inclusion
• Tumor classification (American Joint Committee on Cancer 8th) T2-T4 N0-N3
• Patient in complete remission at inclusion
• patient's consent's obtained after information

Exclusion Criteria:

• Previous treatment for upper aerodigestive tract cancer
• Incomplete radiotherapyTreatment
• Neurological pathology wich may affect the functions of the upper aerodigestive tract
• Pregnant or breastfeeding woman
• Unweaned alcoholism
• Tracheotomized patient at the time of the study
• Patient under protection: subjects with guardianship or under law protection
• No health insurance coverage

Related Conditions & MeSH terms

• Apnea
• Carcinoma, Squamous Cell
• Obstructive Sleep Apnea-hypopnea
• Oropharyngeal Cancer
• Oropharyngeal Neoplasms
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
France	CHU Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of obstructive sleep apnea hypopnea syndrome after treatment by combined chemoradiotherapy.	Number of patients with obstructive sleep apnea hypopnea syndrome after treatment combined chemoradiotherapy.	Day 28
Secondary	Severity of OSAHS as a function of the post-therapeutic delay.	Value of the AHI as a function of the post-therapeutic delay which corresponds to the delay compared to the end of the curative treatment carried out for squamous cell carcinoma of the oropharynx. It is obtained after the inclusion visit and the realization of the polygraphy with the IAH score. OSAHS is mild (if IAH = 5 / h and <15 / h), moderate (if IAH = 15 / h and = 30 / h) or severe (if IAH> 30 / h)	Day 28