Radiotherapy of Head and Neck Cancer Using an Intraoral Stent
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Details and patient eligibility
About
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.
Full 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.
Enrollment
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Inclusion and exclusion criteria
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
220 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Einar Dale, MD PhD
Data sourced from clinicaltrials.gov
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