NCT04337853

Radiotherapy of Tongue Cancer Using an Intraoral Stent

Implementation of an Intraoral Stent in Radiotherapy of Tongue Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Radiotherapy of tongue 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 will give lower dose to the palate throughout the treatment period.

Detailed description

Radiotherapy of tongue 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 main objective of the present study is to confirm that the use of an intraoral stent will result in lower dose to the palate throughout the treatment period. A secondary objective is to measure the reduction in acute mucositis in the palate. The intraoral stent used in the present study is available in two sizes, 10 and 20mm thickness. The intervention group and control group will consist of approximately five patients each. Target coverage will be measured by the minimum dose covering 98% of the clinical target volume (D98CTV). Dose to the organs at risk (hard and soft palate) will be measured by the mean dose. Data will be collected from the planning computed tomography (CT) and daily cone-beam CT (CBCT). Acute mucositis will be scored by Common Terminology Criteria for Adverse Events (CTCAE) v3.0.

Conditions

• Tongue Cancer

Interventions

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

Timeline

• Start date: 2018-03-09
• Primary completion: 2018-12-04
• Completion: 2018-12-04
• First posted: 2020-04-08
• Last updated: 2023-11-03

Locations

1 site across 1 country: Norway