Obstructive Sleep Apnea Syndrome In Patients Treated For Cancer Of The Upper Aerodigestive Tract

Overview

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)

Full Title of Study: “Obstructive Sleep Apnea Syndrome In Patients Treated For Cancer Of The Upper Aerodigestive Tract : The SAOS-K Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 31, 2021

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).

Clinical Trial Outcome Measures

Primary Measures

  • Occurence of obstructive sleep apnea syndrome
    • Time Frame: 3 months after the end of treatment for cancer of the upper aerodigestive tract
    • Obstructive sleep apnea syndrome is defined by an apnea-hypopnea index greater than or equal to 15 per hour

Secondary Measures

  • Delay in onset of obstructive sleep apnea syndrome after completion of cancer treatment
    • Time Frame: during the 6 months follow-up
    • Delay in onset of obstructive sleep apnea syndrome after completion of cancer treatment
  • Epworth score
    • Time Frame: at 3 months and 6 months
    • The Epworth auto-questionnaire, rated from 0 (better) to 24 (worse), assess day-time sleapiness.
  • Occurence of obstructive sleep apnea syndrome
    • Time Frame: 6 months after the end of treatment for cancer of the upper aerodigestive tract
    • Obstructive sleep apnea syndrome is defined by an apnea-hypopnea index greater than or equal to 15 per hour

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre Hospitalier Sud Francilien
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Sandrine Baron, MD, Principal Investigator, Centre Hospitalier Sud Francilien
  • Overall Contact(s)
    • Elodie Henry, CRU manager, +33161693730, elodie.henry@chsf.fr

Citations Reporting on Results

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.

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.

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.

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.

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