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Completed

NCT Number: NCT04337853

Radiotherapy of Tongue Cancer Using an Intraoral Stent

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.

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Key information

Conditions

Tongue Cancer Head and Neck Neoplasms Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Site Stomatognathic Diseases Tongue Diseases Tongue Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Oslo University Hospital

Oslo, N-0424, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intraoral stent

Device

Radiotherapy with intraoral stent

No intraoral stent

Other

Radiotherapy without intraoral stent

Primary outcomes

  1. Reduction in mean dose to the hard palate

    Time frame: At the end of radiotherapy (5-6 weeks)

    Mann-Whitney U test.

Secondary outcomes

  1. Reduction in mean dose to the soft palate

    Time frame: At the end of radiotherapy (5-6 weeks)

    Mann-Whitney U test.

  2. Reduction in acute mucositis in the hard palate

    Time frame: At the end of radiotherapy (5-6 weeks)

    CTCAE score in the hard palate. Mann-Whitney U test.

  3. Reduction in acute mucositis in the soft palate

    Time frame: At the end of radiotherapy (5-6 weeks)

    CTCAE score in the hard palate. Mann-Whitney U test.

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Oslo Metropolitan University

Registry information

Official study title

Implementation of an Intraoral Stent in Radiotherapy of Tongue Cancer

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 8, 2020
Registry last updated
Nov 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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