By InvitationNot Applicable

DENTOFACIAL-PBT Stage 2 - Feasibility Study

United Kingdom255 participantsStarted 2026-01-16

Plain-language summary

What is the health problem? Proton beam therapy (PBT), a type of radiotherapy treatment, can be especially beneficial to children and teenagers with cancer. PBT works by damaging cancer cells, but it can also damage healthy parts of the body nearby. This can include the teeth and jaws if the cancer is in the head and neck region. Unfortunately, the investigators do not yet fully understand the potential side effects of PBT on the teeth or jaws. What is the aim? The DENTOFACIAL-PBT research project aims to learn about the side effects to the teeth and jaws in children treated with PBT. This stage of the research aims to determine how frequently issues ('toxicities') in the development of the teeth and growth of the jaws have occurred in previously treated patients. DENTOFACIAL-PBT is funded by the National Institute for Health and Care Research. How is the researched being approached? The investigators will ask head and neck childhood cancer survivors treated with PBT overseas or in Manchester to support this research. Surveys will be sent initially, asking questions about their teeth and jaws after treatment. If interested, these survivors can be involved in the next part of this stage, which is a mixed-methods feasibility study. This will involve online interviews and dental assessments with some and the collection of dental information from a participant's dentist. Radiation dose to the teeth and the jaw bones will then be linked to any side effects seen. What will be the outcome? The information gained in this study will allow the research team to look at how age, location and amount of dose given affects the toxicities seen. Information learnt will help develop the final stage of the DENTOFACIAL-PBT study. In this, a new toxicity reporting tool will be developed which aims to improve the communication between dentists, doctors, and cancer patients.

Who can participate

Age range

2 Years – 32 Years

Sex

ALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

INCLUSION CRITERIA FOR THE SURVEY AND FEASIBILITY STUDY (steps A-D): * (i) CCS previously diagnosed with HNC. This includes the oral cavity (lips, front two-thirds of the tongue, the gums, the lining inside the cheeks and lips, the floor of the mouth, under the tongue and the hard palate), the throat (nasopharynx, oropharynx and hypopharynx), the voice box (larynx), the paranasal sinuses, nasal cavity and the salivary glands * (ii) Any sex. * (iii) Currently a minimum age of 2 years. * (iv) Treated with PBT at The Christie PBT centre (Manchester, UK) or treated overseas with PBT as part of the NHS Proton Overseas Programme. * (v) Completed treatment with PBT when aged 15 years and under. * (vi) Completed treatment with PBT more than 12 months ago. * (vii) Able and willing to provide informed consent or informed consent provided by a parent or person with parental responsibility in law for a child currently aged less than 16 years old who meets the inclusion criteria outlined in (i) to (vi). * (viii) Language - Capacity to translate study documents and conduct interviews in the following languages: English, Arabic, Chinese, Dutch, French, German, Italian, Portuguese, Russian, Spanish and Turkish. INCLUSION CRITERIA FOR STEP E OF THE FEASIBILITY STUDY * (i) CCS previously diagnosed with HNC. This includes the oral cavity (lips, front two-thirds of the tongue, the gums, the lining inside the cheeks and lips, the floor of the mouth, under the tongue and the hard palate), the t…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Recruitment rate and number of participants with complete datasets.

Timeframe: From enrolment until study completion, an average of 1 year.

Presence of dentofacial toxicities

Timeframe: Through study completion, an average of 1 year.

Trial details

NCT IDNCT07057284

SponsorManchester University NHS Foundation Trust

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2026-09-30

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