Combination Therapy: Hyperbaric Oxygen and PENTOCLO for Treatment of Osteoradionecrosis of the Mandible
Status:
Not yet recruiting
Trial end date:
2025-11-01
Target enrollment:
Participant gender:
Summary
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.