DENTOFACIAL-PBT Stage 2 - Feasibility Study

Launched by MANCHESTER UNIVERSITY NHS FOUNDATION TRUST · Jun 30, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a special type of cancer treatment called proton beam therapy (PBT) on the teeth and jaws of children and teenagers who had cancer in the head or neck area. While PBT is helpful in fighting cancer, it can sometimes affect healthy parts nearby, like teeth and jawbones, but doctors don’t yet fully understand how often or how badly this happens. This study aims to find out how common these side effects are and how factors like age and radiation dose might influence them.

Children and young people who had head or neck cancer, were treated with PBT before they turned 16, and finished their treatment at least a year ago may be eligible to take part. Participants will first be asked to complete a survey about their teeth and jaws after treatment. Some may also be invited to join online interviews and dental check-ups, where their dental records and treatment details will be reviewed. The information collected will help doctors and dentists better understand these side effects and improve how they talk with patients about them in the future. If you or a family member fits these criteria and are interested, this study offers a chance to help improve care for children with similar experiences.

Gender

ALL

Eligibility criteria

• 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 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 old for a clinical assessment without a radiograph to be conducted. The minimum age of a participant that a radiograph will be attempted at is 3 years old.
• • (iv) Referred for PBT treatment by the Oncology team at The Royal Manchester Children's Hospital.
• • (v)Treated with PBT at The Christie PBT centre (Manchester, UK) or treated overseas with PBT as part of the NHS Proton Overseas Programme.
• • (vi) Completed treatment with PBT when aged 15 years and under.
• • (vii) Completed treatment with PBT more than 12 months ago.
• • (viii) Attending annual review clinics at either The Royal Manchester Children's Hospital ("follow-up clinic") or at The Christie NHS Foundation Trust ("late effects clinic") with the Oncology team.
• • (ix) 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 (viii).
• • (x) Language - English, Arabic, Chinese, Dutch, French, German, Italian, Portuguese, Russian, Spanish and Turkish.
• • EXCLUSION CRITERIA FOR THE SURVEY AND FEASIBILITY STUDY (steps A-D)
• • (i) Deceased patients
• • (ii) Aged greater than or equal to 16 years old at the time of diagnosis
• • (iii) Currently aged less than 2 years old
• • (iv) Completed PBT less than 12 months ago. (Although the minimal follow-up time for dentofacial toxicities to develop is unknown, it is felt that setting this restriction will enable eligible participants to have processed their treatment and had multiple reviews within this first year. This criterion of follow-up was discussed with the developed patient advisory group and this timeframe was felt to be the most appropriate).
• • (v) Individuals treated with PBT overseas but not referred from a UK centre (not in the Proton Overseas Programme). For example, individuals whose care was privately funded or funded by an insurance company. The PCO Database maintained by the PCOU will not hold outcome data for privately funded patients.
• • (vi) A parent or person with parental responsibility in law for a CCS now aged greater than 16 years old.
• • (vii) Exclusion of any participant who does not speak a language specified in the inclusion criteria.
• • EXCLUSION CRITERIA FOR STEP E OF THE FEASIBILITY STUDY
• • (i) Deceased patients
• • (ii) Aged greater than or equal to 16 years old at the time of diagnosis
• • (iii) Currently aged less than 2 years old
• • (iv) Completed PBT less than 12 months ago.
• • (v) Individuals treated with PBT overseas but not referred from a UK centre (not in the Proton Overseas Programme). For example, individuals whose care was privately funded or funded by an insurance company.
• • (vi) No radiation delivered to the maxilla, mandible and/or teeth.
• • (vii) A parent or person with parental responsibility in law for a CCS now aged greater than 16 years old.
• • (viii) Living outside of the Greater Manchester region and not attending routine annual clinics with the Oncology team at The Royal Manchester Children's Hospital or at The Christie NHS Foundation Trust.
• • (ix) Exclusion of any participant who does not speak a language specified in the inclusion criteria.