Combination Therapy: Hyperbaric Oxygen and PENTOCLO for Treatment of Osteoradionecrosis of the Mandible
Osteoradionecrosis, Osteoradionecrosis of Jaw, Osteoradionecrosis of the Mandible
About this trial
This is an interventional treatment trial for Osteoradionecrosis focused on measuring Osteoradionecrosis, ORN, PENtoxifylline, TOcopherol and CLOdronate, PENTOCLO, Hyperbaric Oxygen Therapy, HBOT, Head and Neck Cancer, Radiation Therapy
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 Has no contraindications for undergoing hyperbaric oxygen therapy as assessed by a Hyperbaric Physician, and is willing to commit the time to undergo 60 sessions Exclusion Criteria: Inability to give informed consent Previous treatment for ORN (PENTOCLO, HBOT or surgery) Major surgical procedure planned (more extensive than sequestrectomy) Severe trismus and inability to obtain intraoral photographs Contraindications for HBOT: pneumothorax, bullous disease, uncontrolled hypertension, uncontrolled epilepsy, claustrophobia Contraindications to mPENTOCLO: inability to swallow medication; pregnancy or lactating; allergy to any study drug; currently on oral anticoagulants; hemorrhagic/coagulation disorder; Vitamin K deficiency; active unresolved cardiac disease; severe liver or kidney disease (CrCl < 30 mL/min)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
Group 1 (Control)
Group 2 (Intervention)
Standard of care treatment for ORN consisting of conservative measures (e.g. local irrigation, antiseptic mouthwash) and approximately 60 hyperbaric oxygen therapy (HBOT) treatments (90 minute exposures at 2.4 ATA each, scheduled Monday to Friday for 12 weeks - i.e., 5 treatments per week). At the conclusion of the study and at the discretion of the clinical team, patients randomized to the control group with residual disease may be considered for the mPENTOCLO protocol. Simultaneously, the 4-week mPENTOCLO "pre-treatment" phase will be started (as defined in the intervention section), followed by a sham/placebo mPENTOCLO treatment phase for a total of 12 months.
Standard of care treatment as described for the control group (conservative measures and 60 HBOT treatments). Simultaneously, a comprehensive oral regimen (mPENTOCLO) will be started, including a 4-week "pre-treatment phase" followed by a "treatment phase" for a total of 12 months, as defined in the Intervention section.