Radiotherapy of Head and Neck Cancer Using an Intraoral S... | NCT04330781

Studies
Radiotherapy of Head and Neck Cancer Using an Intraoral Stent

NCT04330781

Sponsor

Oslo University Hospital

Status

Completed

Last Update Posted

Jul 9, 2025Actual

Enrollment

220Actual

Phase

Phase 2

Conditions

Oral Cavity Cancer
Sinonasal Cancer

Interventions

Intraoral stent
No intraoral stent

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2020Actual

Primary Completion Date

Jul 3, 2025Actual

Completion Date

Jul 8, 2025Actual

First Submitted Date

Mar 31, 2020

First Submission Date that Met QC Criteria

Mar 31, 2020

First Posted Date

Apr 1, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 8, 2025

Last Update Posted Date

Jul 9, 2025Actual

Name	Class
Oslo Metropolitan University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

220Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention group	Experimental	N=123	Device: Intraoral stent
Control group	Active Comparator	N=31	Other: No intraoral stent

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intraoral stent	Device	Radiotherapy with intraoral stent	Intervention group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Einar Dale, MD PhD	Senior Consultant	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oslo University Hospital		Oslo		N-0424	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Background	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.

ID	Term
D009062	Mouth Neoplasms
D006258	Head and Neck Neoplasms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D009059	Mouth Diseases
D009057	Stomatognathic Diseases