Actively Recruiting
Combination Therapy: Hyperbaric Oxygen and PENTOCLO for Treatment of Osteoradionecrosis of the Mandible
Led by Sunnybrook Health Sciences Centre · Updated on 2025-09-12
24
Participants Needed
1
Research Sites
149 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 hyperbaric oxygen therapy (HBOT), which may requires up to 60 treatments at a specialized clinic where patients are treated with high concentrations of oxygen using special chambers, and a less complex option called PENTOCLO which involves treating patients with several antibiotics followed by a combination of other oral medications taken for at least 1 year. This pilot study will be guide the design of a definitive trial to examine if the combination of HBOT and a modified PENTOCLO protocol together is better than the current standard treatment of HBOT alone. Outcomes will include pain, side effects and the need for surgery in patients with ORN. Specifically, the results of this small, pilot study will help to inform the design of a future larger study.
CONDITIONS
Official Title
Combination Therapy: Hyperbaric Oxygen and PENTOCLO for Treatment of Osteoradionecrosis of the Mandible
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of mandibular osteoradionecrosis after completing radiotherapy
- Presence of exposed dead irradiated bone larger than 20 mm2
- No contraindications for hyperbaric oxygen therapy as determined by a specialist
- Willing to commit to up to 60 hyperbaric oxygen therapy sessions
- Negative pregnancy test for women of childbearing potential not using accepted birth control
- Recent ECG test within 60 days before enrolling
- Age 18 years or older
You will not qualify if you...
- Unable to give informed consent
- Previous treatment for osteoradionecrosis (PENTOCLO, HBOT, or surgery)
- Planned major surgery beyond sequestrectomy
- Severe jaw muscle tightness preventing oral photos
- Contraindications for hyperbaric oxygen therapy such as pneumothorax, bullous disease, uncontrolled hypertension, uncontrolled epilepsy, or claustrophobia
- Contraindications to modified PENTOCLO including inability to swallow, pregnancy or lactation, allergies to study drugs, use of oral anticoagulants, bleeding disorders, Vitamin K deficiency, active serious heart disease, severe liver or kidney disease
- Documented QT prolongation on ECG unless corrected before enrollment
- Need for medications that strongly prolong QT interval unless safely stopped or changed
- History of liver problems related to amoxicillin-clavulanate
- Moderate to severe active liver disease or high liver enzyme levels
- History of myasthenia gravis
- History of severe tendon disorders or peripheral neuropathy from antibiotics
- Smoking, high alcohol use, sepsis, severe malnutrition, or serious immune system problems
- Ongoing or recurrent cancer
- Vitamin K deficiency or taking extra Vitamin E
- Use of anti-resorptive or anti-angiogenic medications
- Diagnosis of retinitis pigmentosa
- Clinically significant anemia
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N3M5
Actively Recruiting
Research Team
B
Ben Safa, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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