New beam angle may spare cancer patients from dry mouth and swallowing woes
NCT ID NCT07413627
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a new way of aiming radiation beams (non-coplanar) can reduce side effects like dry mouth and swallowing problems in people with head and neck cancer. About 70 adults with cancer of the mouth or throat will be randomly assigned to standard or new radiation. The main goal is to see if quality of life improves three months after treatment.
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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 70 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2029
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: * Age ≥ 18 years * Patient diagnosed with non-operated, non-metastatic squamous cell carcinoma of the oral cavity or oropharynx, histologically confirmed, with p16 status determined by immunohistochemistry, and indicated for curative bilateral radiotherapy, with or without concomitant chemotherapy * Patient scheduled to receive standard photobiomodulation treatment protocol during radiotherapy * ECOG performance status ≤ 2 * Presence of xerostomia \< 1 according to CTCAE v6.0 at pre-inclusion * Patient able to provide informed consent and capable of complying with study follow-up, including visits for completion of quality of life questionnaires and salivary tests * Patient affiliated with a social security system or equivalent Inclusion Criteria (RECOARD 2.0 recommendations) to be confirmed with the information provided by the simulation/plan treatment CT scan : \- Exceedance of a dose constraint for at least one Organ at Risk (OAR) as defined below with a coplanar beam arrangement : * The average dose delivered to at least one parotid gland must be greater than 26 Grays, and/or =\> 65% of the oral cavity receives a dose greater than 30 Grays, and/or * The average dose delivered to at least one submandibular gland must be greater than 32 Grays, and/or * The average dose delivered to the larynx exceeds 43.5 Grays. Exclusion Criteria: * Other head and neck locations than the oral cavity and oropharynx, and/or a surgically treated UADT cancer, and/or radiotherapy treatment already started. * Histologies other than squamous cell carcinoma * Tumors requiring only unilateral irradiation. * Non-curative irradiation and/or metastatic patient * Double tumor localization * Previous history of head and neck radiotherapy. * Inability to comply with study follow-up visits and medical assessments due to geographical, social, or psychological reasons. * Individuals under legal custody or guardianship (including curatorship). * Pregnant or breastfeeding women (pregnancy test required at inclusion).
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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
1 site. 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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Centre Georges-François Leclerc
Dijon, 21000, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Lighting up oral cancer: dye may help surgeons see tumor edges
- MRI-Guided tweaks during radiation could spare throat cancer patients from swallowing woes
- Can a One-Two punch of immunotherapy and radiation wipe out head and neck tumors before surgery?
- Mouth rinse could ease painful radiation side effects for head and neck cancer patients
- New drug aims to spare cancer patients from debilitating mouth sores