Radiotherapy of Head and Neck Cancer Using an Intraoral Stent

Phase 2

Completed

• Conditions: Oral Cavity Cancer; Sinonasal Cancer

• Registration Number: NCT04330781
• Lead Sponsor: Oslo University Hospital

Brief 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.

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-03-31
• Study First Submitted QC: 2020-03-31
• Study First Posted: 2020-04-01
• Status Verified: 2024-12
• Primary Completion: 2025-07-03
• Study Completion: 2025-07-08
• Last Update Submitted: 2025-07-08
• Last Update Posted: 2025-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patient-reported outcome	At the end of radiotherapy (5-6 weeks)	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

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway