Xerostomia after submandibular gland sparing radiotherapy
Phase 3
Completed
- Conditions
- oropharyngeal cancer10027656
- Registration Number
- NL-OMON31993
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
Patients treated with radiotherapy for squamous cell carcinoma of the oropharynx.
Exclusion Criteria
Previous radiotherapy of the salivary glands
Previous surgery of the salivary glands
Malignancies or other diseases of the salivary glands
TNM stages N2c and N3
Distant metastatic disease
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The number of patients with patient-reported xerostomia one year after<br /><br>radiotherapy determined using questionnaires (EORTC QLQ-H&N 35).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Objectively determined submandibulair flow complication. A complication is<br /><br>defined as a submandibular flow less than 25% of the pre-radiotherapy values.<br /><br><br /><br>General quality of life after submandibular gland sparing radiotherapy.<br /><br><br /><br>Radiation-induced damage to the salivary system detected by MRI. </p><br>