Radiotherapy of Tongue Cancer Using an Intraoral Stent

Tongue Cancer Clinical Trial

Official title:

Implementation of an Intraoral Stent in Radiotherapy of Tongue Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04337853
• Other study ID #: 2018-139
• Status: Completed
• Phase: Phase 1
• Start date: March 9, 2018
• Est. completion date: December 4, 2018

Study information

• Verified date: November 2023
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: December 4, 2018
• Est. primary completion date: December 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with tongue cancer
• Curatively intended radiotherapy requiring a total dose of 50-70 Gy
• Age >18 years
• Performance status, Eastern Cooperative Oncology Group (ECOG) 0-2 Exclusion Criteria: None

Related Conditions & MeSH terms

• Tongue Cancer
• Tongue Neoplasms

Intervention

Device:
• Intraoral stent
Radiotherapy with intraoral stent

Other:
• No intraoral stent
Radiotherapy without intraoral stent

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	Oslo Metropolitan University

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in mean dose to the hard palate	Mann-Whitney U test.	At the end of radiotherapy (5-6 weeks)
Secondary	Reduction in mean dose to the soft palate	Mann-Whitney U test.	At the end of radiotherapy (5-6 weeks)
Secondary	Reduction in acute mucositis in the hard palate	CTCAE score in the hard palate. Mann-Whitney U test.	At the end of radiotherapy (5-6 weeks)
Secondary	Reduction in acute mucositis in the soft palate	CTCAE score in the hard palate. Mann-Whitney U test.	At the end of radiotherapy (5-6 weeks)

External Links

•   Results