Smart radiation aims to cut severe mouth sores in head and neck cancer
NCT ID NCT06297902
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares standard radiation therapy to a newer method called dose painting for people with head and neck cancer. The goal is to see if dose painting causes fewer severe mouth ulcers one year after treatment. About 100 participants will be randomly assigned to receive either standard or experimental radiation. The experimental approach gives a higher dose to the most active part of the tumor while aiming to spare healthy tissue.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2024
- Expected to finish
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Jun 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Histologically or cytologically verified invasive squamous cell carcinoma of the head and neck region; Sinonasal cancer, oral cavity cancer, hypopharynx cancer, larynx cancer, HPV negative oropharyngeal cancer and T4 (any N) HPV positive oropharyngeal cancer. 2. Patients planned for standard curative RT (with or without concomitant chemotherapy \[cisplatin, or cetuximab\], with or without nimorazole hypoxic cell radiosensitizer) 3. Age \> 18 years 4. WHO performance status 0-2 5. Signed informed consent 6. Ability to understand information about the study and to complete questionnaires Exclusion Criteria: 1. All diagnoses, cT1 cN0-N1 cM0 2. Glottic cancer cT1-T2 cN0 cM0 3. HPV positive oropharyngeal carcinoma T1-T3 (any N) 4. Diabetes mellitus 5. Use of anticoagulant medication 6. Active smoking and/or alcohol abuse
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Haukeland University Hospital
RECRUITINGBergen, N-5021, Norway
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Oslo University Hospital
RECRUITINGOslo, Norway
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St. Olavs Hospital
NOT_YET_RECRUITINGTrondheim, N-7006, Norway
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a dental assistant keep cancer Patients' mouths healthier during radiation?
- Why do Non-Smokers get head and neck cancer? scientists probe tumor DNA
- Re-irradiation plus cetuximab targets head and neck tumors that return
- Sharper tumor maps: PET scans could tighten radiation beams
- Lighting up oral cancer: dye may help surgeons see tumor edges
- Blood test aims to catch Cancer's return earlier