Prediction of Radiation-induced Swallowing Dysfunction after Curative (Chemo)Radiation for Head and Neck Cancer

Phase 2

Completed

• Conditions: dysphagia; swallowing complaints; 10027655

• Registration Number: NL-OMON31538
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 240

Inclusion Criteria

- primary head and neck cancer (or lymph node metastases from an unknown primary)
- stage I-IV (UICC staging system 2002)
- no distant metastases
- no postoperative radiotherapy / chemo-radiotherapy
- previously untreated

Exclusion Criteria

- distant metastases
- surgery

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Grade 2 or more swallowing dysfunction at 6 months after completion of<br /><br>(chemo)radiation (according to the RTOG/EORTC system).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Findings of videofluoroscopy.<br /><br>• Dysphagia, Esophageal Morbidity and Aspiration according to the Common<br /><br>Terminology Criteria for Adverse Events version 3.0.<br /><br>• Thickening of the pharyngeal constrictor muscles, the pharyngeal and<br /><br>laryngeal mucosa on CT-scan<br /><br>• Health related quality of life (EORTC QLQ-C30 and EORTC QLQ-H&N35)<br /><br>• Patient-rated swallowing complaints (SWAL-QoL) </p><br>