NCT04330781

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2020

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 1, 2020

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2025

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2025

Completed
Last Updated

July 9, 2025

Status Verified

December 1, 2024

Enrollment Period

5.5 years

First QC Date

March 31, 2020

Last Update Submit

July 8, 2025

Conditions

Oral Cavity CancerSinonasal Cancer

Keywords

RadiotherapyIntraoral stentHead and neck cancerPatient-reported outcome

Outcome Measures

Primary Outcomes (1)

  • Patient-reported outcome

    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)

Study Arms (2)

Intervention group

EXPERIMENTAL

N=123

Device: Intraoral stent

Control group

ACTIVE COMPARATOR

N=31

Other: No intraoral stent

Interventions

Intraoral stentDEVICE

Radiotherapy with intraoral stent

Intervention group
No intraoral stentOTHER

Radiotherapy without intraoral stent

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, N-0424, Norway

Location

Related Publications (1)

  • Bø 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.

    BACKGROUND

MeSH Terms

Conditions

Mouth NeoplasmsHead and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsMouth DiseasesStomatognathic Diseases

Study Officials

  • Einar Dale, MD PhD

    Senior Consultant

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Consultant

Study Record Dates

First Submitted

March 31, 2020

First Posted

April 1, 2020

Study Start

January 1, 2020

Primary Completion

July 3, 2025

Study Completion

July 8, 2025

Last Updated

July 9, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)