Radiotherapy of Head and Neck Cancer Using an Intraoral Stent

Oral Cavity Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04330781
• Other study ID #: 2019-38
• Status: Recruiting
• Phase: Phase 2
• Start date: January 1, 2020
• Est. completion date: December 2025

Study information

• Verified date: November 2023
• Source: Oslo University Hospital
• Contact: Einar Dale, MD PhD
• Phone: +4722934000
• Email: eindal[@]ous-hf.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 154
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Radiation dose 30 Gy or higher
• Cancer in the inferior part of the oral cavity (e.g. tongue or floor of mouth cancer) or superior part of the oral cavity (e.g. hard palate) or sinonasal cancer
• Eastern Cooperative Oncology Group (ECOG) performance status 0-3
• Ability to understand and answer questionnaire Exclusion Criteria: None

Related Conditions & MeSH terms

• Mouth Neoplasms
• Oral Cavity Cancer
• Sinonasal Cancer

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	Patient-reported outcome	Less than 10% change (non-inferiority) in sum of pain scores (no 31-34) in questionnaire European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - H&N 35 plus 3 extra questions regarding pain in the palate, tongue and lips	At the end of radiotherapy (5-6 weeks)