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New radiation approach aims to cut painful side effects in head and neck cancer

NCT ID NCT07580300

Symptom relief Sponsor: Oslo University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests if proton radiation causes fewer side effects than standard photon radiation in people with head and neck cancer. About 400 adults aged 40 and older will receive either proton or photon therapy, plus possible chemotherapy. The main goal is to see if protons reduce problems like dry mouth, trouble swallowing, pain, and speech issues during the year after treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Apr 2055

An estimate. End dates often move.

Lead sponsor

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

40 to 90 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Signed informed consent. 2. Age ≥ 40 years. 3. Histological or cytological verified squamous cell carcinoma of the following head and neck regions; oral cavity, oropharynx, hypopharynx or larynx. 4. Planned for standard radiotherapy with curative intent, either as definitive or postoperative treatment with or without concomitant chemotherapy (cisplatin). 5. ECOG performance status 0-2. 6. Ability to fill in patient questionnaires and comply with study procedures. 7. Able to answer questionnaires in Norwegian or English. 8. Willing to travel to Oslo or Bergen for proton therapy if randomised to experimental arm. Exclusion Criteria: 1. Glottic cancers, cT1-T2 cN0 cM0. 2. Nasopharyngeal carcinomas, sino-nasal cancers, and head and neck salivary gland carcinomas. 3. Distant metastasis. 4. Previous radiotherapy to the head and neck. 5. Patients with pacemakers and/or implanted defibrillators. 6. Prior malignancy within the last 5 years. Not including radically resected non-melanoma skin cancer or low-risk early-stage prostate cancer. 7. Not able to participate due to equipment restrictions (weight limit treatment board 150 kg). 8. Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could, at the investigator's opinion, interfere with the participant's safety or study participation.

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Conditions

The condition(s) this trial relates to.

head and neck squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HNSCC

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Haukeland University Hospital

    NOT_YET_RECRUITING

    Bergen, 5051, Norway

  • Oslo University Hospital, Radiumhospitalet

    RECRUITING

    Oslo, 0379, Norway

  • St. Olavs Hospital

    NOT_YET_RECRUITING

    Trondheim, 7006, Norway

  • University Hospital of Northern Norway

    NOT_YET_RECRUITING

    Tromsø, 9038, Norway

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