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.
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