Clinical trial · Interventional
Radiotherapy of Head and Neck Cancer Using an Intraoral Stent
Patient-reported Outcome After Radiotherapy of Oral Cavity and Sinonasal Cancer Using an Intraoral Stent
NCT04330781CI-TRIAL-00091915completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 reduce side-effects. The aim of the present study is to confirm that an intraoral stent is not a significant bother to the patients.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Cavity Cancer | Malignant Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
| Sinonasal Cancer | Malignant Sinonasal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intraoral stent | Device | — | UNRESOLVED |
| No intraoral stent | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention group
- description
- N=123
- interventionNames
- Device: Intraoral stent
- type
- ACTIVE_COMPARATOR
- label
- Control group
- description
- N=31
- interventionNames
- Other: No intraoral stent
Primary outcomes (1)
- measure
- Patient-reported outcome
- timeFrame
- At the end of radiotherapy (5-6 weeks)
- description
- Less than 10% change (non-inferiority) in sum of pain scores (no 31-34) in questionnaire European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - H\&N 35 plus 3 extra questions regarding pain in the palate, tongue and lips
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: None
References
Publications (1)
- BACKGROUNDBø B, Furre T, Dale E. Radiotherapy of tongue cancer using an intraoral stent: a pilot study. Journal of Radiotherapy in Practice. 2021;21(3):370-6.