Implementation of an Intraoral Stent in Radiotherapy of Tongue Cancer
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 13
- Locations
- 2
- Primary Endpoint
- Reduction in mean dose to the hard palate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
- Not provided
Arms & Interventions
Control group
N=7
Intervention: No intraoral stent (Other)
Intervention group
N=6
Intervention: Intraoral stent (Device)
Outcomes
Primary Outcomes
Reduction in mean dose to the hard palate
Time Frame: At the end of radiotherapy (5-6 weeks)
Mann-Whitney U test.
Secondary Outcomes
- Reduction in mean dose to the soft palate(At the end of radiotherapy (5-6 weeks))
- Reduction in acute mucositis in the soft palate(At the end of radiotherapy (5-6 weeks))
- Reduction in acute mucositis in the hard palate(At the end of radiotherapy (5-6 weeks))
Investigators
Einar Dale
Senior Consultant
Oslo University Hospital