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

NCT ID: NCT04262453

Last Updated: 2023-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

142 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-21

Study Completion Date

2023-09-20

Brief Summary

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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

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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).

Conditions

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Upper Aerodigestive Tract Neoplasms Obstructive Sleep Apnea-hypopnea Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Sud Francilien

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sandrine Baron, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Sud Francilien

Locations

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Centre Hospitalier Sud Francilien

Corbeil-Essonnes, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 28543072 (View on PubMed)

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.

Reference Type RESULT
PMID: 23575744 (View on PubMed)

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.

Reference Type RESULT
PMID: 28332763 (View on PubMed)

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.

Reference Type RESULT
PMID: 25273079 (View on PubMed)

Other Identifiers

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2018-A02373-52

Identifier Type: -

Identifier Source: org_study_id

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