Osteoradionecrosis (bone death caused by irradiation) Oral Health
Conditions
Interventions
Participants are randomised to receive either PENTOCLO (pentoxifylline, tocopherol, clodronate) or standardised supportive care (e.g. antibiotics, mouthwash and painkillers).
Dose:
Pentoxifylline 800
Sponsors
University of Liverpool
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A diagnosis of mandibular ORN 2. Patients considered suitable for medical management 3. Written and informed consent obtained from participant and agreement of participant to comply with the requirements of the study 4. Aged 18 years and over
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 09/01/2024: 1. Cannot swallow tablets 2. Prior treatment with PENTOCLO or any element thereof within 12 months of the date of randomisation 3. Very early ORN (75 mg*, ticlopidine, dipyridamole. (*low dose =75 mg aspirin is permitted) 11.11. Concomitant prescription of ketorolac, cimetidine, ciprofloxacin, theophylline, estramustine phosphate 11.12. Hereditary fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency 11.13. Concomitant prescription other bisphosphonates e.g. risedronate, alendronate, aIbandronate, zoledronic acid, pamidronate, etidronate or prescription of denosusamab 11.14. Concomitant prescription of aminoglycoside antibiotics e.g. gentamicin, tobramycin, amikacin, plazomicin, streptomycin, neomycin, paromomycin _____ Previous exclusion criteria: 1. Cannot swallow tablets 2. Prior treatment with PENTOCLO or any element thereof within 12 months of the date of randomisation 3. Very early ORN (<20 mm² exposed bone) occurring within 12 months of a dental extraction or other dentoalveolar operation (‘Minor Bone Spicules’ see flowchart below) 4. Mandibular pathological fracture secondary to ORN 5. Extra-oral communicating fistula secondary to ORN 6. Prior surgery/jaw resection 7. Pregnancy 8. Lactation 9. Age <18 years 10. Acute infection at site of the necrotic bone. 11. Contraindications to PENTOCLO medications: 11.1. Known hypersensitivity, allergy or anaphylaxis to pentoxifylline, tocopherol or sodium clodronate 11.2. Treated hypotension 11.3. Severe coronary artery disease, defined as grade IV of the Canadian Cardiology Society Angina Grading 11.4. Severe atrial fibrillation, defined as grade 4 on modified CCC-SAF 11.5. Myocardial infarction within 6 months 11.6. Prior history of extensive retinal haemorrhage 11.7. Prior histo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to healing (defined as the complete elimination of exposed bone without the need for surgery), measured every 3 months following randomisation until the end of the trial for that patient | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured every 3 months following randomisation until the end of the trial for that patient unless otherwise noted: 1. PROMs (patient-reported outcome measures) of symptoms related to ORN recorded every 15 days: pain, eating, trismus, swelling 2. Time to treatment failure/progression, measured as the time from randomisation until worsening ORN or the clinical need for mandibular resection and reconstruction 3. Analgesia and antibiotic usage recorded at 3-monthly appointments 4. Mandibular preservation rate measured by general head and neck and intra-oral examination every 3 months 5. Notani grade of ORN recorded at 3-monthly appointments 6. Dimensions of exposed bone between baseline and primary endpoint measured using clinical photograph with in-field ruler 7. Severity of disease and overall quality of life measured using Common Toxicity Criteria for Adverse Events (CTCAE)/Subjective, objective, management and analytic (SOMA)/Quality of Life (QOL) scores 8. Patients’ weight and height measurements recorded at 3 monthly visits to calculate the BMI (kg/m²) 9. Compliance, gastrointestinal tolerability and toxicity of PENTOCLO measured using the CTCAE | — |
Countries
England, United Kingdom
Outcome results
None listed