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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04337853
Other study ID # 2018-139
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date March 9, 2018
Est. completion date December 4, 2018

Study information

Verified date November 2023
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 13
Est. completion date December 4, 2018
Est. primary completion date December 4, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Intraoral stent
Radiotherapy with intraoral stent
Other:
No intraoral stent
Radiotherapy without intraoral stent

Locations

Country Name City State
Norway Oslo University Hospital Oslo

Sponsors (2)

Lead Sponsor Collaborator
Oslo University Hospital Oslo Metropolitan University

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reduction in mean dose to the hard palate Mann-Whitney U test. At the end of radiotherapy (5-6 weeks)
Secondary Reduction in mean dose to the soft palate Mann-Whitney U test. At the end of radiotherapy (5-6 weeks)
Secondary 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)
Secondary 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)
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