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Radiotherapy of Head and Neck Cancer Using an Intraoral Stent

Primary Purpose

Oral Cavity Cancer, Sinonasal Cancer

Status

Recruiting

Phase

Phase 2

Locations

Norway

Study Type

Interventional

Intervention

Intraoral stent

No intraoral stent

About this trial

This is an interventional treatment trial for Oral Cavity Cancer focused on measuring Radiotherapy, Intraoral stent, Head and neck cancer, Patient-reported outcome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

Radiotherapy target both in the superior part of the oral cavity and elective neck level I

Sites / Locations

Oslo University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention group

Control group

Arm Description

N=123

N=31

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04330781

First Posted

March 31, 2020

Last Updated

August 25, 2022

Sponsor

Oslo University Hospital

Collaborators

Oslo Metropolitan University

1. Study Identification

Unique Protocol Identification Number

NCT04330781

Brief Title

Radiotherapy of Head and Neck Cancer Using an Intraoral Stent

Official Title

Patient-reported Outcome After Radiotherapy of Oral Cavity and Sinonasal Cancer Using an Intraoral Stent

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2020 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Oslo University Hospital

Collaborators

Oslo Metropolitan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Oral Cavity Cancer, Sinonasal Cancer

Keywords

Radiotherapy, Intraoral stent, Head and neck cancer, Patient-reported outcome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

154 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention group

Arm Type

Experimental

Arm Description

N=123

Arm Title

Control group

Arm Type

Active Comparator

Arm Description

N=31

Intervention Type

Device

Intervention Name(s)

Intraoral stent

Intervention Description

Radiotherapy with intraoral stent

Intervention Type

Other

Intervention Name(s)

No intraoral stent

Intervention Description

Radiotherapy without intraoral stent

Primary Outcome Measure Information:

Title

Patient-reported outcome

Description

Time Frame

At the end of radiotherapy (5-6 weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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: Radiotherapy target both in the superior part of the oral cavity and elective neck level I

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Einar Dale, MD PhD

Phone

+4722934000

eindal@ous-hf.no

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Einar Dale, MD PhD

Organizational Affiliation

Senior Consultant

Official's Role

Principal Investigator

Facility Information:

Facility Name

Oslo University Hospital

City

Oslo

ZIP/Postal Code

N-0424

Country

Norway

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Einar Dale, MD PhD

Phone

+4722934000

eindal@ous-hf.no

First Name & Middle Initial & Last Name & Degree

Berit Bø, BSc

First Name & Middle Initial & Last Name & Degree

Torbjørn Furre, MSc

12. IPD Sharing Statement

Plan to Share IPD

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Radiotherapy of Head and Neck Cancer Using an Intraoral Stent

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