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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04330781

Enrollment

220

Registered

2020-04-01

Start date

2020-01-01

Completion date

2025-07-08

Last updated

2025-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Cavity Cancer, Sinonasal Cancer

Keywords

Radiotherapy, Intraoral stent, Head and neck cancer, Patient-reported outcome

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 reduce side-effects. The aim of the present study is to confirm that an intraoral stent is not a significant bother to the patients.

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 tolerated the stent. The mean radiation dose to the hard palate was reduced by 61% (absolute percentage) as compared with a control group not using the stent. Based on these results, the investigators wish to perform a study on a larger cohort to confirm that the intraoral stent will not lead to increased symptoms towards the end of the radiotherapy period.

Interventions

DEVICEIntraoral stent

Radiotherapy with intraoral stent

OTHERNo intraoral stent

Radiotherapy without intraoral stent

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

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

Design outcomes

Primary

Measure	Time frame	Description
Patient-reported outcome	At the end of radiotherapy (5-6 weeks)	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

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026