Radiotherapy of Head and Neck Cancer Using an Intraoral Stent

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Oral Cavity Cancer, Sinonasal Cancer

Intervention / Treatment
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* Device: Intraoral stent
* Other: No intraoral stent


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>N=123 | Device: Intraoral stent<br>* Radiotherapy with intraoral stent<br>|
| Active Comparator: Control group<br>N=31 | Other: No intraoral stent<br>* Radiotherapy without intraoral stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiotherapy, Intraoral stent, Head and neck cancer, Patient-reported outcome