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

Launched by SUNNYBROOK HEALTH SCIENCES CENTRE · Sep 19, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment approach for a serious condition called osteoradionecrosis (ORN) of the jaw, which can occur after radiation therapy for head and neck cancers. ORN happens when bone tissue in the jaw dies due to damage from radiation, leading to painful and open areas in the mouth that can be challenging to treat. The study is testing the combination of two treatments: hyperbaric oxygen therapy (HBOT), where patients breathe pure oxygen in a special chamber, and a modified version of a treatment called PENTOCLO, which involves taking antibiotics and other oral medications for at least a year. Researchers want to find out if this combination works better than HBOT alone in reducing pain, minimizing side effects, and decreasing the need for surgery.

To participate in this trial, candidates must be at least 18 years old and have been diagnosed with ORN after receiving radiation therapy. They should be willing to undergo up to 60 sessions of HBOT and not have any conditions that would prevent them from safely receiving this treatment. Potential participants will also need to meet certain health criteria to ensure they can safely take part in the study. While this trial is not yet recruiting participants, it aims to gather valuable information that could help shape future research and improve treatment options for people with ORN.

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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
• • 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
• • Negative Human Chronic Gonadotropin (hCG) screening test at baseline (for female patients of reproductive age not practicing medically acceptable methods of birth control (e.g., hormonal contraceptives, implants, injectables, intrauterine device (IUD), intrauterine system (IUS), vasectomy and bilateral tubal ligation)
• • Baseline in-date ECG (within 60 days prior to enrolment)
• • Age ≥ 18
• 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)
• • Known QT prolongation as documented on an in-date ECG (within 60 days prior to enrolment)
• • Currently on other drugs known to prolong the QT interval (e.g., erythromycin, cisapride, astemizole, pimozide or quinidine)
• • History of cholestatic jaundice/hepatic dysfunction associated with amoxicillin-clavulanate
• • Moderate to severe liver disease (due potential for drug induced liver dysfunction)
• • History of myasthenia gravis
• • Patients with a history of nontraumatic tendon disorders or have experienced nontraumatic tendinitis or tendon rupture
• • Patients who have previously experienced peripheral neuropathy due to exposure to antibiotics
• • Smokers, high alcohol intake (average of \>2 standard drinks per day), sepsis, severe undernourishment and severe immunodeficiency conditions (e.g. HIV, autoimmune disease, immune-compromised)
• • Persistent or recurrent cancer and active neoplastic pathology will be excluded
• • Patients with documented Vitamin K deficiency
• • Patients taking additional Vitamin E
• • Patients who have received previous anti-resorptive or anti-angiogenic medications
• • Patients diagnosed with retinitis pigmentosa
• • Patients diagnosed with clinically significant anemia