Tongue Cancer
Conditions
Keywords
Radiotherapy, Head and neck cancer, Intraoral stent
Brief summary
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
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.
Interventions
DEVICEIntraoral stent
Radiotherapy with intraoral stent
OTHERNo intraoral stent
Radiotherapy without intraoral stent
Sponsors
Oslo Metropolitan University
Oslo University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in mean dose to the hard palate | At the end of radiotherapy (5-6 weeks) | Mann-Whitney U test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in acute mucositis in the hard palate | At the end of radiotherapy (5-6 weeks) | CTCAE score in the hard palate. Mann-Whitney U test. |
| Reduction in acute mucositis in the soft palate | At the end of radiotherapy (5-6 weeks) | CTCAE score in the hard palate. Mann-Whitney U test. |
| Reduction in mean dose to the soft palate | At the end of radiotherapy (5-6 weeks) | Mann-Whitney U test. |
Countries
Norway
Outcome results
None listed