Radiotherapy of Head and Neck Cancer Using an Intraoral Stent

  • STATUS
    Recruiting
  • End date
    Feb 28, 2023
  • participants needed
    154
  • sponsor
    Oslo University Hospital
Updated on 3 March 2022
head and neck cancer
caries
neck cancer
carcinoma of oral cavity

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.

Details
Condition Oral Cavity Cancer, Sinonasal Cancer
Treatment Intraoral stent, No intraoral stent
Clinical Study IdentifierNCT04330781
SponsorOslo University Hospital
Last Modified on3 March 2022

Eligibility

Yes No Not Sure

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

Radiotherapy target both in the superior part of the oral cavity and elective neck level I
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