Radiotherapy of Tongue Cancer Using an Intraoral Stent

Study Overview
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Brief Summary
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Radiotherapy of tongue 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 will give lower dose to the palate throughout the treatment period.

Detailed Description
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Radiotherapy of tongue 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 main objective of the present study is to confirm that the use of an intraoral stent will result in lower dose to the palate throughout the treatment period. A secondary objective is to measure the reduction in acute mucositis in the palate. The intraoral stent used in the present study is available in two sizes, 10 and 20mm thickness. The intervention group and control group will consist of approximately five patients each. Target coverage will be measured by the minimum dose covering 98% of the clinical target volume (D98CTV). Dose to the organs at risk (hard and soft palate) will be measured by the mean dose. Data will be collected from the planning computed tomography (CT) and daily cone-beam CT (CBCT). Acute mucositis will be scored by Common Terminology Criteria for Adverse Events (CTCAE) v3.0.

Official Title
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Implementation of an Intraoral Stent in Radiotherapy of Tongue Cancer

Conditions
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Tongue 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: Patients with tongue cancer Curatively intended radiotherapy requiring a total dose of 50-70 Gy Age >18 years Performance status, Eastern Cooperative Oncology Group (ECOG) 0-2 Exclusion Criteria: None

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=6 | Device: Intraoral stent<br>* Radiotherapy with intraoral stent<br>|
| Active Comparator: Control group<br>N=7 | 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 |
| --- | --- | --- |
| Reduction in mean dose to the hard palate | Mann-Whitney U test. | At the end of radiotherapy (5-6 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in mean dose to the soft palate | Mann-Whitney U test. | At the end of radiotherapy (5-6 weeks) | 
| Reduction in acute mucositis in the hard palate | CTCAE score in the hard palate. Mann-Whitney U test. | At the end of radiotherapy (5-6 weeks) | 
| Reduction in acute mucositis in the soft palate | CTCAE score in the hard palate. Mann-Whitney U test. | 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, Head and neck cancer, Intraoral stent