Radiotherapy of Head and Neck Cancer Using an Intraoral Stent

Sponsor

Oslo University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04330781

Collaborator

Oslo Metropolitan University (Other)

154

Enrollment

Location

Arms

37.9

Anticipated Duration (Months)

4.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Oral Cavity Cancer Sinonasal Cancer	Device: Intraoral stent Other: No intraoral stent	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

154 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2020

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Feb 28, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Patient-reported outcome [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oslo University Hospital	Oslo		Norway	N-0424

Sponsors and Collaborators

Oslo University Hospital
Oslo Metropolitan University

Investigators

Principal Investigator: Einar Dale, MD PhD, Senior Consultant

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Einar Dale, Senior Consultant, Oslo University Hospital

ClinicalTrials.gov Identifier:

NCT04330781

Other Study ID Numbers:

2019-38

First Posted:

Apr 1, 2020

Last Update Posted:

Jun 8, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Einar Dale, Senior Consultant, Oslo University Hospital

Radiotherapy

Intraoral stent

Head and neck cancer

Patient-reported outcome

Additional relevant MeSH terms:

Mouth Neoplasms

Study Results

No Results Posted as of Jun 8, 2021