Radiotherapy of Tongue Cancer Using an Intraoral Stent

Implementation of an Intraoral Stent in Radiotherapy of Tongue Cancer

Radiotherapy of tongue 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 will give lower dose to the palate throughout the treatment period.

Study Overview

• Status: Completed
• Conditions: Tongue Cancer
• Intervention / Treatment: Device: Intraoral stent; Other: No intraoral stent

Detailed Description

Radiotherapy of tongue 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 main objective of the present study is to confirm that the use of an intraoral stent will result in lower dose to the palate throughout the treatment period. A secondary objective is to measure the reduction in acute mucositis in the palate.

The intraoral stent used in the present study is available in two sizes, 10 and 20mm thickness. The intervention group and control group will consist of approximately five patients each. Target coverage will be measured by the minimum dose covering 98% of the clinical target volume (D98CTV). Dose to the organs at risk (hard and soft palate) will be measured by the mean dose. Data will be collected from the planning computed tomography (CT) and daily cone-beam CT (CBCT). Acute mucositis will be scored by Common Terminology Criteria for Adverse Events (CTCAE) v3.0.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 1

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, N-0424
    • Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with tongue cancer
• Curatively intended radiotherapy requiring a total dose of 50-70 Gy
• Age >18 years
• Performance status, Eastern Cooperative Oncology Group (ECOG) 0-2

Exclusion Criteria:

None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; N=6	Device: Intraoral stent; Radiotherapy with intraoral stent
Active Comparator: Control group; N=7	Other: No intraoral stent; Radiotherapy without intraoral stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in mean dose to the hard palate	Mann-Whitney U test.	At the end of radiotherapy (5-6 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in mean dose to the soft palate	Mann-Whitney U test.	At the end of radiotherapy (5-6 weeks)
Reduction in acute mucositis in the hard palate	CTCAE score in the hard palate. Mann-Whitney U test.	At the end of radiotherapy (5-6 weeks)
Reduction in acute mucositis in the soft palate	CTCAE score in the hard palate. Mann-Whitney U test.	At the end of radiotherapy (5-6 weeks)

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: Oslo Metropolitan University
• Investigators: Principal Investigator: Einar Dale, MD PhD, Oslo University Hospital, Department of Oncology

Publications and helpful links

Helpful Links

• Results

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2018
• Primary Completion (Actual): December 4, 2018
• Study Completion (Actual): December 4, 2018

Study Registration Dates

• First Submitted: April 5, 2020
• First Submitted That Met QC Criteria: April 5, 2020
• First Posted (Actual): April 8, 2020

Study Record Updates

• Last Update Posted (Actual): November 3, 2023
• Last Update Submitted That Met QC Criteria: November 1, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Radiotherapy; Head and neck cancer; Intraoral stent
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Stomatognathic Diseases; Mouth Diseases; Mouth Neoplasms; Tongue Diseases; Tongue Neoplasms
• Other Study ID Numbers: 2018-139

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No