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NCT07057284

DENTOFACIAL-PBT Stage 2 - Feasibility Study

Sponsor: Manchester University NHS Foundation Trust

View on ClinicalTrials.gov

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.

Official title: DENtofacial TOxicity: Facilitating Advancement in Paediatric Cancer toxIcity Reporting And Liaison in Proton Beam Therapy. Stage 2 - Feasibility of Retrospective Toxicity Outcome Collection [DENTOFACIAL-PBT(2)]

Key Details

Gender

All

Age Range

2 Years - 32 Years

Study Type

OBSERVATIONAL

Enrollment

255

Start Date

2026-01-16

Completion Date

2027-01-31

Last Updated

2026-01-26

Healthy Volunteers

Conditions

Head and Neck Cancer Radiotherapy Side Effect Adverse Effect of Radiation Therapy Childhood Cancer Dental Developmental Disorders and Anomalies Facial Deformity Jaw; Developmental Disorder Radiation Toxicity

Interventions

RADIATION

Orthopantomogram (or a set of Lateral Oblique Radiographs)

A dental assessment will be conducted on eligible participants who still attend annual review appointments in the Oncology Departments at the Royal Manchester Children's Hospital or at The Christie NHS Foundation Trust (approximately 10% of eligible study population). The dental assessment will include the following: a tooth chart, a basic periodontal examination (BPE), a brief orthodontic assessment (incisor, molar and skeletal classification including any asymmetry), caries assessment and an assessment of any dental development disturbances. Clinical photographs of the teeth and face will be taken with a patient's consent. If clinically justified, an OPT will be taken. If cooperation for an OPT proves challenging, lateral obliques as an alternative radiographic image modality will be considered.

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.

Locations (2)

Manchester University NHS Foundation Trust

Manchester, United Kingdom

The Christie NHS Foundation Trust