Prevention of radiation-induced parotid gland dysfunction by parotid-gland stem-cell sparing intensity-modulated radiotherapy (SCS-IMRT)

Phase 3

Completed

• Conditions: Radiotherapie complicaties: Xerostomie; dry-mouth syndrome; xerostomia; 10017990; 10017991

• Registration Number: NL-OMON36912
• Lead Sponsor: niversitair Medisch Centrum Groningen

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: 102

Inclusion Criteria

Patients treated with planned curative primary radiotherapy for HNC, with or without chemotherapy or cetuximab meeting the following criteria:
- Squamous cell carcinoma originating from the mucosa of the head and neck area or nasofaryngeal carcinoma originating from the nasofarynx;
- The radiotherapy includes prophylactic or therapeutic irradiation of both sides of the neck (at least level II to IV);
- Age * 18 years;
- WHO performance 0-2;
- pre-treatment stimulated parotid gland saliva production >0.2 ml/min.

Exclusion Criteria

- Postoperative radiotherapy;
- Re-irradiation;
- Unilateral radiotherapy;
- Primary salivary gland tumours

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Incidence of parotid gland dysfunction (reduction of saliva production to less<br /><br>than 25% of the production pre-radiotherapy.)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Physician-rated xerostomia (CTCAE v4.0)<br /><br>GRIX questionnaire (Groningen Radiation Induced Xerostomia questionnaire)<br /><br>Patient-rated xerostomia (questionnare EORTC QLQ-H&N35)</p><br>