Radiotherapy of Head and Neck Cancer Using an Intraoral Stent

NCT ID: NCT04330781

Last Updated: 2025-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2025-07-08

Brief Summary

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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

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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.

Conditions

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Oral Cavity Cancer Sinonasal Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention group

N=123

Group Type EXPERIMENTAL

Intraoral stent

Intervention Type DEVICE

Radiotherapy with intraoral stent

Control group

N=31

Group Type ACTIVE_COMPARATOR

No intraoral stent

Intervention Type OTHER

Radiotherapy without intraoral stent

Interventions

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Intraoral stent

Radiotherapy with intraoral stent

Intervention Type DEVICE

No intraoral stent

Radiotherapy without intraoral stent

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo Metropolitan University

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Einar Dale

Senior Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Einar Dale, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Senior Consultant

Locations

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Oslo University Hospital

Oslo, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type BACKGROUND

Other Identifiers

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2019-38

Identifier Type: -

Identifier Source: org_study_id

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