Status:
ACTIVE_NOT_RECRUITING
Prospective Pilot Study Evaluating Dental Side Effects of Radiotherapy on Subjects Treated for Head and Neck Cancer
Lead Sponsor:
Jules Bordet Institute
Conditions:
Head and Neck Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Multi-centric, one arm phase II study. The first phase of the study will consist of an evaluation of the initial dental state of each subject based on a stomatological examination, an orthopantomogram...
Eligibility Criteria
Inclusion
- Age ≥ 18 years old
- ECOG performance status ≤2
- Female and Male
- Newly diagnosed, histologically or cytologically confirmed head and neck squamous cell carcinoma (oropharynx, oral cavity, larynx, hypopharynx or cavum)
- Results of previous pre-treatment imaging (PET-CT and cervicofacial MRI and/or CT/scan)
- Eligible for treatment based on (chemo-)radiotherapy (with or without a surgical treatment)
- Agree to wear, three times per week, fluoride dental splint after RT
- HPV/p 16 testing results available at the time of screening (only for subjects with oropharynx cancer)
- Serum pregnancy test (for subjects of childbearing potential) negative within 7 days prior to the 1st radiotherapy treatment
- Women of childbearing potential must agree to use of one effective method of contraception prior study entry and during the course of the study.
- Completion of all necessary screening procedures within 30 days prior to 1st radiotherapy treatment.
- Signed Informed Consent form (ICF) obtained prior to any study related procedure.
- Ability to understand and complete the questionnaires (language proficiency, cognitive functioning) as judged by the principal investigator upon screening
- Note: Subject from the SwallPEG trial can participate in the StomRay study if they meet all of the previous eligibility criteria.
Exclusion
- Subject having less than ten teeth on dental arch
- Life expectancy less than 12 months
- History of previous head and neck irradiation
- Prior or current treatment with bisphosphonates or denosumab
- Presence of too many metal artefacts on the RT simulation scan preventing precise teeth contouring
- Subject with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator's opinion, may interfere with completion of the study.
- Pregnancy and/or lactating women
- Subjects with imperfect amelogenesis
Key Trial Info
Start Date :
November 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 16 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04452032
Start Date
November 17 2020
End Date
May 16 2027
Last Update
November 8 2024
Active Locations (3)
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1
CHU saint Pierre
Brussels, Belgium, 1000
2
Hôpital Erasme
Brussels, Belgium, 1070
3
Institut Jules Bordet
Brussels, Belgium, 1070