Xerostomia after submandibular gland sparing radiotherapy

Xerostomia after submandibular gland sparing radiotherapy - Xerostomia after radiotherapy

Status

Active, not recruiting

Phases

Phase 3

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON31993

Enrollment

Registered

2009-01-13

Start date

2009-02-24

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

oropharyngeal cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients treated with radiotherapy for squamous cell carcinoma of the oropharynx.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
The number of patients with patient-reported xerostomia one year after radiotherapy determined using questionnaires (EORTC QLQ-H&N 35).	—

Secondary

Measure	Time frame
Objectively determined submandibulair flow complication. A complication is defined as a submandibular flow less than 25% of the pre-radiotherapy values. General quality of life after submandibular gland sparing radiotherapy. Radiation-induced damage to the salivary system detected by MRI.	—

Countries

Netherlands

Outcome results