Combination Therapy: Hyperbaric Oxygen and PENTOCLO for Treatment of Osteoradionecrosis of the Mandible

Recruiting Phase 3 Interventional Study
Osteoradionecrosis Osteoradionecrosis of Jaw Osteoradionecrosis of the Mandible
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
24 (estimated)
Sponsor
Sunnybrook Health Sciences Centre · Other
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About This Trial
Radiation is commonly used to treat cancer in the head and neck, however, this can lead to a serious complication called osteoradionecrosis (ORN), where there is necrotic (dead) open bone inside or outside of the mouth. This complication is difficult to treat, involves large healthcare costs, and can have devastating effects on quality of life. Two common adjuncts used in treatment of ORN are hyp…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Diagnosis of mandibular ORN after completion of radiotherapy * ORN will be defined as "an area of exposed devitalized irradiated bone (\> 20 mm2)"; minor bone spicules (MBS) (\< 20 mm2) in the absence of radiographic abnormality, will be considered clinically insignificant * H…
Contacts

Ben Safa, MD

416-480-4864

ben.safa@sunnybrook.ca

CONTACT