Back to resultsRadiotherapy of Tongue Cancer Using an Intraoral Stent
Primary Purpose
Tongue Cancer
Status
Completed
Phase
Phase 1
Locations
Norway
Study Type
Interventional
Intervention
Intraoral stent
No intraoral stent
Sponsored by
About this trial
This is an interventional treatment trial for Tongue Cancer focused on measuring Radiotherapy, Head and neck cancer, Intraoral stent
Eligibility Criteria
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
Sites / Locations
- Oslo University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention group
Control group
Arm Description
N=6
N=7
Outcomes
Primary Outcome Measures
Reduction in mean dose to the hard palate
Mann-Whitney U test.
Secondary Outcome Measures
Reduction in mean dose to the soft palate
Mann-Whitney U test.
Reduction in acute mucositis in the hard palate
CTCAE score in the hard palate. Mann-Whitney U test.
Reduction in acute mucositis in the soft palate
CTCAE score in the hard palate. Mann-Whitney U test.
Full Information
NCT ID
NCT04337853
First Posted
April 5, 2020
Last Updated
June 6, 2021
Sponsor
Oslo University Hospital
Collaborators
Oslo Metropolitan University
1. Study Identification
Unique Protocol Identification Number
NCT04337853
Brief Title
Radiotherapy of Tongue Cancer Using an Intraoral Stent
Official Title
Implementation of an Intraoral Stent in Radiotherapy of Tongue Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
March 9, 2018 (Actual)
Primary Completion Date
December 4, 2018 (Actual)
Study Completion Date
December 4, 2018 (Actual)
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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tongue Cancer
Keywords
Radiotherapy, Head and neck cancer, Intraoral stent
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
N=6
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
N=7
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
Reduction in mean dose to the hard palate
Description
Mann-Whitney U test.
Time Frame
At the end of radiotherapy (5-6 weeks)
Secondary Outcome Measure Information:
Title
Reduction in mean dose to the soft palate
Description
Mann-Whitney U test.
Time Frame
At the end of radiotherapy (5-6 weeks)
Title
Reduction in acute mucositis in the hard palate
Description
CTCAE score in the hard palate. Mann-Whitney U test.
Time Frame
At the end of radiotherapy (5-6 weeks)
Title
Reduction in acute mucositis in the soft palate
Description
CTCAE score in the hard palate. Mann-Whitney U test.
Time Frame
At the end of radiotherapy (5-6 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Einar Dale, MD PhD
Organizational Affiliation
Oslo University Hospital, Department of Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
N-0424
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.cambridge.org/core/journals/journal-of-radiotherapy-in-practice/article/radiotherapy-of-tongue-cancer-using-an-intraoral-stent-a-pilot-study/EA0903883867854A0190757E4CF9777A#
Description
Results
Learn more about this trial
Radiotherapy of Tongue Cancer Using an Intraoral Stent
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