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

PHASE3RecruitingINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

January 16, 2025

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2027

Conditions
OsteoradionecrosisOsteoradionecrosis of JawOsteoradionecrosis of the Mandible
Interventions
DRUG

modified PENTOCLO (mPENTOCLO)

"4-week pre-treatment phase consisting of 2 g daily of Amoxicillin+Clavulanic acid 875/125 mg (1 g morning and night), 1 g ciprofloxacin (500 mg morning and night) and 50 mg Fluconazole daily (morning), taken orally by the patient.~This is followed by an additional 11 months (12 months total) treatment phase consisting of 800 mg pentoxifylline (400 mg morning and night) and 800 IU tocopherol (400 IU morning and night) taken orally 5 days per week (Monday to Friday with no medications on Saturday and Sunday). If the patient deteriorates (i.e., worsening of ORN T 6 or 9-month follow-up) then clodronate 1600 mg once daily (Monday to Friday) for the rest of the study period will be added."

DRUG

sham mPENTOCLO

"4-week pre-treatment phase consisting of 2 g daily of Amoxicillin+Clavulanic acid 875/125 mg (1 g morning and night), 1 g ciprofloxacin (500 mg morning and night) and 50 mg Fluconazole daily (morning), taken orally by the patient.~This is followed by an additional 11 months (12 months total) of sham treatment phase (placebo)."

Trial Locations (1)

M4N3M5

RECRUITING

Sunnybrook Health Sciences Centre, Toronto

All Listed Sponsors
lead

Sunnybrook Health Sciences Centre

OTHER