Clinical trial NCT04262453: Obstructive Sleep Apnea Syndrome In Patients Treated For Cancer Of The Upper Aerodigestive Tract
Official title: Obstructive Sleep Apnea Syndrome In Patients Treated For Cancer Of The Upper Aerodigestive Tract : The SAOS-K Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Upper Aerodigestive Tract Neoplasms
Obstructive Sleep Apnea-hypopnea Syndrome
Keywords: Upper Aerodigestive Tract Neoplasms
Obstructive Sleep Apnea-hypopnea Syndrome
Epworth score
Ventilatory Polygraphy
Lead sponsor: Centre Hospitalier Sud Francilien
Sponsor class: OTHER
First posted: 2020-02-10
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with a recently discovered upper aerodigestive tract tumour who have not yet started treatment

Brief summary: Prospective open-label, non-randomized, monocentric, cohort study, to assess the prevalence and severity of sleep apnea syndrome in patients treated for cancer of the upper aerodigestive tract.

The patient follows a usual course of care including, at the end of the treatment of his cancer of the upper aerodigestive tract, screening for obstructive sleep apnea syndrome at 3 months and 6 months (Epworth score and ventilatory polygraphy)

Detailed description: Prospective open-label, non-randomized, monocentric, cohort study, to assess the prevalence and severity of sleep apnea syndrome in patients treated for cancer of the upper aerodigestive tract.

Patients are included in the study when they are hospitalized for panendoscopy. Thereafter, it takes about 1 month to start any treatment. The duration of treatment is estimated at about 5 months (the longest regimen would be induction chemotherapy followed by surgery and adjuvant complementary treatment). After which the patient follows a usual course of care including, at the end of the treatment of his cancer of the upper aerodigestive tract, screening for obstructive sleep apnea syndrome at 3 months and 6 months (Epworth score and ventilatory polygraphy).

Eligibility criteria: Inclusion Criteria:

* macroscopic lesion suggestive of a cancerous tumour of the upper aerodigestive tract (oral cavity, oropharynx, larynx, hypopharynx, cavum, cervical lymph node metastases with an occult primary cancer)
* awaiting anatomopathological confirmation

Exclusion Criteria:

* history of cancer of the upper aerodigestive tract
* history of known obstructive sleep apnea syndrome
* cancer of the thyroid, salivary glands, nose and paranasal sinuses
* patients under guardianship or curatorship

Primary outcomes:
measure: Occurence of obstructive sleep apnea syndrome
timeFrame: 3 months after the end of treatment for cancer of the upper aerodigestive tract
Secondary outcomes:
measure: Delay in onset of obstructive sleep apnea syndrome after completion of cancer treatment
timeFrame: during the 6 months follow-up
measure: Epworth score
timeFrame: at 3 months and 6 months
measure: Occurence of obstructive sleep apnea syndrome
timeFrame: 6 months after the end of treatment for cancer of the upper aerodigestive tract
Other outcomes:
Locations:
city: Corbeil-Essonnes
country: France
facility: Centre Hospitalier Sud Francilien
Study officials:
affiliation: Centre Hospitalier Sud Francilien
name: Sandrine Baron, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Huyett P, Kim S, Johnson JT, Soose RJ. Obstructive sleep apnea in the irradiated head and neck cancer patient. Laryngoscope. 2017 Nov;127(11):2673-2677. doi: 10.1002/lary.26674. Epub 2017 May 23.
citation: Gilat H, Shpitzer T, Guttman D, Soudry E, Feinmesser R, Bachar G. Obstructive sleep apnea after radial forearm free flap reconstruction of the oral tongue. Laryngoscope. 2013 Dec;123(12):3223-6. doi: 10.1002/lary.24125. Epub 2013 Apr 10.
citation: Loth A, Michel J, Giorgi R, Santini L, Rey M, Elbaum JM, Roux N, Giovanni A, Dessi P, Fakhry N. Prevalence of obstructive sleep apnoea syndrome following oropharyngeal cancer treatment: A prospective cohort study. Clin Otolaryngol. 2017 Dec;42(6):1281-1288. doi: 10.1111/coa.12869. Epub 2017 Apr 18.
citation: Faiz SA, Balachandran D, Hessel AC, Lei X, Beadle BM, William WN Jr, Bashoura L. Sleep-related breathing disorders in patients with tumors in the head and neck region. Oncologist. 2014 Nov;19(11):1200-6. doi: 10.1634/theoncologist.2014-0176. Epub 2014 Oct 1.