Tongue CancerPhase 1NCT04337853
Radiotherapy of Tongue Cancer Using an Intraoral Stent
A Phase 1 study testing Intraoral stent and No intraoral stent in people with Tongue Cancer, run by Oslo University Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tongue Cancer
- What is being tested?
- Intraoral stent and No intraoral stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteNorway
- Study dates
- 9 Mar 2018to 4 Dec 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Tongue Cancer
- Being tested
- Intraoral stent, No intraoral stent
- Keywords
- Radiotherapy, Head and neck cancer, Intraoral stent
- Medical subject headings
- Tongue Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoral stentDevice
Radiotherapy with intraoral stent
No intraoral stentOther
Radiotherapy without intraoral stent
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | N=6 Receives: Device: Intraoral stent |
| Control group | Active comparator | N=7 Receives: Other: No intraoral stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in mean dose to the hard palate
Mann-Whitney U test.
Measured: At the end of radiotherapy (5-6 weeks)
Secondary outcomes (3)
Reduction in mean dose to the soft palate
Mann-Whitney U test.
Measured: 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.
Measured: 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.
Measured: At the end of radiotherapy (5-6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2020
- Study start9 Mar 2018
- Primary completion4 Dec 2018
- Study completion4 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tongue CancerStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo Metropolitan University
- Responsible party
- Principal investigator, Einar Dale, Oslo University Hospital
- Investigators
- Einar Dale, MD PhD, Principal investigator, Oslo University Hospital, Department of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04337853
- Sponsor's protocol ID
- 2018-139
- Status last verified
- Nov 2023
- First submitted
- 5 Apr 2020
- Last updated
- 3 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of an Intraoral Stent in Radiotherapy of Tongue Cancer
- ClinicalTrials.gov ID
- NCT04337853
- Acronym / sponsor ID
- 2018-139
- Conditions
- Tongue Cancer
- Keywords
- Radiotherapy, Head and neck cancer, Intraoral stent
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Oslo Metropolitan University
- Study start
- 9 Mar 2018 (actual)
- Primary completion
- 4 Dec 2018 (actual)
- Study completion
- 4 Dec 2018 (actual)
- First posted
- 8 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Intraoral stentN=6 |
| Control group | Active comparator | Other: No intraoral stentN=7 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoral stentRadiotherapy with intraoral stent | Device | Intervention group |
| No intraoral stentRadiotherapy without intraoral stent | Other | Control group |
Primary outcome
Reduction in mean dose to the hard palate
Time frame: At the end of radiotherapy (5-6 weeks)
Mann-Whitney U test.
3 secondary outcomes
Reduction in mean dose to the soft palate
Time frame: At the end of radiotherapy (5-6 weeks)
Reduction in acute mucositis in the hard palate
Time frame: At the end of radiotherapy (5-6 weeks)
Reduction in acute mucositis in the soft palate
Time frame: At the end of radiotherapy (5-6 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
- ResultsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Tongue Cancer
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A Study Comparing Personalized Radiation Therapy With Standard Radiation Therapy in People With HPV-Positive Throat Cancer
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Einar Dale, MD PhD principal investigator
Oslo University Hospital, Department of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Intraoral stent and No intraoral stent in people with Tongue Cancer, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in mean dose to the hard palate (time frame: At the end of radiotherapy (5-6 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2023.