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Completed

NCT Number: NCT04330781

Radiotherapy of Head and Neck Cancer Using an Intraoral Stent

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.

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Key information

Conditions

Oral Cavity Cancer Head and Neck Neoplasms Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Site Sinonasal Cancer Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Oslo University Hospital

Oslo, N-0424, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intraoral stent

Device

Radiotherapy with intraoral stent

No intraoral stent

Other

Radiotherapy without intraoral stent

Primary outcomes

  1. Patient-reported outcome

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Oslo Metropolitan University

Registry information

Official study title

Patient-reported Outcome After Radiotherapy of Oral Cavity and Sinonasal Cancer Using an Intraoral Stent

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Apr 1, 2020
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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