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| Name | Class |
|---|---|
| Oslo Metropolitan University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | N=6 |
|
| Control group | Active Comparator | N=7 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraoral stent | Device | Radiotherapy with intraoral stent |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in mean dose to the hard palate | Mann-Whitney U test. | At the end of radiotherapy (5-6 weeks) |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
None
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| Name | Affiliation | Role |
|---|---|---|
| Einar Dale, MD PhD | Oslo University Hospital, Department of Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital | Oslo | N-0424 | Norway |
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| ID | Term |
|---|---|
| D014062 | Tongue Neoplasms |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009062 | Mouth Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009059 | Mouth Diseases |
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| No intraoral stent |
| Other |
Radiotherapy without intraoral stent |
|
| 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) |
| D009057 |
| Stomatognathic Diseases |
| D014060 | Tongue Diseases |