Preventive Swallowing Exercises to prevent persistent swallowing dysfunction after curative (chemo)-radiation in head and neck cancer

Phase 2

Completed

• Conditions: head and neck cancer; shoulderproblems; speech; swallowing; 10027656

• Registration Number: NL-OMON36292
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 90

Inclusion Criteria

Head and neck squamous cell cancer, with the primary site origination in the oral cavity, oropharynx, hypopharynx, nasopharynx and larynx or patients with lymph node metastases from an unknown primary tumor
Stage I - IV (UICC staging system 2002)
planned for curative RT with or without chemotherapy / cetuximab

Exclusion Criteria

serious cognitive impairment
lack of basic fluency in the Dutch language

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>RTOG/EORTC late radiation morbidity scoring schema for dysphagia</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>RTOG acute dysphagia<br /><br>tube feeding dependency at 6 months after competion of (chemo-)radiation<br /><br>quality of life questionnaires:<br /><br>- EORTC QLQ-H&N35<br /><br>- SWALQOL<br /><br>- SHI<br /><br>- SDQ<br /><br>- EORTC QLQ-C30<br /><br>- EuroQol-5D<br /><br>- HADS</p><br>