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Search / Trial NCT04330781

Radiotherapy of Head and Neck Cancer Using an Intraoral Stent

Launched by OSLO UNIVERSITY HOSPITAL · Mar 31, 2020

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Radiotherapy Intraoral Stent Head And Neck Cancer Patient Reported Outcome

ClinConnect Summary

This clinical trial is studying the use of an intraoral stent during radiotherapy for patients with oral cavity cancer or sinonasal cancer. The intraoral stent is a device that creates more space between the tongue and the roof of the mouth, which may help to reduce side effects from radiation treatment. The main goal of the study is to see if this stent is comfortable for patients and does not cause significant inconvenience during their treatment.

To participate in the trial, you need to be between the ages of 65 and 74 and have been prescribed a radiation dose of at least 30 Gy for your cancer. You should have cancer in specific areas, such as the tongue or the hard palate, and be able to understand and respond to questions about your experience. There are no specific exclusions, so if you meet these criteria, you could be a good fit for the study. If you join, you can expect to wear the stent during your radiotherapy sessions, and researchers will check in with you to understand how you feel about it throughout the process.

Gender

ALL

Eligibility criteria

  • 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

About Oslo University Hospital

Oslo University Hospital is a leading academic medical center in Norway, renowned for its commitment to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical studies, the hospital integrates cutting-edge scientific inquiry with patient care, fostering an environment that promotes the development of new therapies and treatment strategies. With a multidisciplinary approach, Oslo University Hospital collaborates with various stakeholders, including researchers, healthcare professionals, and industry partners, to enhance clinical outcomes and contribute to the global medical community. Its dedication to ethical standards and patient safety ensures that all trials are conducted with the highest level of integrity and respect for participant welfare.

Locations

Oslo, , Norway

Patients applied

0 patients applied

Trial Officials

Einar Dale, MD PhD

Principal Investigator

Senior Consultant

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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