Status:
COMPLETED
Radiotherapy of Head and Neck Cancer Using an Intraoral Stent
Lead Sponsor:
Oslo University Hospital
Collaborating Sponsors:
Oslo Metropolitan University
Conditions:
Oral Cavity Cancer
Sinonasal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 redu...
Detailed Description
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 tolerat...
Eligibility Criteria
Inclusion
- 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
- None
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 8 2025
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT04330781
Start Date
January 1 2020
End Date
July 8 2025
Last Update
July 9 2025
Active Locations (1)
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1
Oslo University Hospital
Oslo, Norway, N-0424