Radiotherapy of Head and Neck Cancer Using an Intraoral Stent

January 19, 2024 updated by: Einar Dale, Oslo University Hospital

Patient-reported Outcome After Radiotherapy of Oral Cavity and Sinonasal 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

154

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Norway
      • Oslo, Norway, N-0424
        • Recruiting
        • Oslo University Hospital
        • Contact:
        • Sub-Investigator:
          • Berit Bø, BSc
        • Sub-Investigator:
          • Torbjørn Furre, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
N=123
Device: Intraoral stent
Radiotherapy with intraoral stent
Active Comparator: Control group
N=31
Other: No intraoral stent
Radiotherapy without intraoral stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At the end of radiotherapy (5-6 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

Oslo Metropolitan University

Investigators

  • Principal Investigator: Einar Dale, MD PhD, Senior Consultant

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

March 31, 2020

First Submitted That Met QC Criteria

March 31, 2020

First Posted (Actual)

April 1, 2020

Study Record Updates

Last Update Posted (Actual)

January 22, 2024

Last Update Submitted That Met QC Criteria

January 19, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-38

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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