NCT04330781

Radiotherapy of Head and Neck Cancer Using an Intraoral Stent

Patient-reported Outcome After Radiotherapy of Oral Cavity and Sinonasal Cancer Using an Intraoral Stent

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Radiotherapy of oral cavity cancer and sinonasal cancer is associated with acute and late morbidity. Use of an intraoral stent will provide a larger distance between the tongue and palate and can reduce side-effects. The aim of the present study is to confirm that an intraoral stent is not a significant bother to the patients.

Detailed description

The investigators have previously performed a pilot study on the feasibility of the intraoral stent in patients receiving radiotherapy for tongue cancer. It was found that most of the patients tolerated the stent. The mean radiation dose to the hard palate was reduced by 61% (absolute percentage) as compared with a control group not using the stent. Based on these results, the investigators wish to perform a study on a larger cohort to confirm that the intraoral stent will not lead to increased symptoms towards the end of the radiotherapy period.

Conditions

• Oral Cavity Cancer
• Sinonasal Cancer

Interventions

Type	Name	Description
DEVICE	Intraoral stent	Radiotherapy with intraoral stent
OTHER	No intraoral stent	Radiotherapy without intraoral stent

Timeline

• Start date: 2020-01-01
• Primary completion: 2025-07-03
• Completion: 2025-07-08
• First posted: 2020-04-01
• Last updated: 2025-07-09

Locations

1 site across 1 country: Norway