Diagnosis and treatment of obstructive sleep apnoea in patients with head and neck squamous cell carcinoma treated with surgery and adjuvant radiation therapy

Recruiting

• Conditions: G47.3; C14; C13; Sleep apnoea; Malignant neoplasm of other and ill-defined sites in the lip, oral cavity and pharynx; Malignant neoplasm of hypopharynx

• Registration Number: DRKS00021692
• Lead Sponsor: niversitätsmedizin Mainz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-26
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

Patients with cT2- cT4 head and neck cancer
- Cancer localization oral, oropharynx, hypopharynx
- Indication to surgery and adjuvant radiochemotherapy
- Age 18 years and older

Exclusion Criteria

- Tracheostomy for the duration of the RCT
- Laryngectomy
- Missing informed consent
- Congestive heart failure (EF < 30%)
- Lung emphysema
- BMI (body mass index) > 38 Kg/m²

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symptomscale fatigue EORTC QLQ C 30<br>Before therapy (point in time 0), after surgery (after 2 weeks), after end of adjuvant therapy (after 8 weeks), during follow up (after 3 and 6 months)

Secondary Outcome Measures

Name	Time	Method
EORTC symptom scales<br>Apnea / hypopnea index (AHI)<br>Epworth Sleepiness Scale (ESS)<br>Pittsburgh Sleep Quality Index (PSQI)<br>Insomnia Severity Index (ISI)<br>CT-scan-based tumor dimensions<br><br>Before therapy, after surgery, after end of adjuvant therapy, during follow up