Protocol for prospective randomised assessor-blinded pilot study comparing hyperbaric oxygen therapy with PENtoxifylline+TOcopherol± CLOdronate for the management of early osteoradionecrosis of the mandible

INTRODUCTION: Osteoradionecrosis (ORN) of the mandible is a painful and debilitating condition occurring after radiotherapy to the head and neck to treat cancer. For decades, hyperbaric oxygen (HBO) has formed the mainstay of the early management of ORN. Literature about the efficacy of HBO is contentious. Recently, Oral and Maxillofacial surgical units in France and UK have trialled a combination of medications to treat ORN, also known as PENTOCLO (PENtoxifylline+TOcopherol±CLOdronate). This regime has shown promising results to date however randomised controlled trials in the area comparing HBO against PENTOCLO are lacking and there are no current trials registered in Europe, UK, Australia and the USA. The purpose of this pilot study is to generate a hypothesis that can be tested in large multi-centre controlled trials. METHODS AND ANALYSIS: For this pilot study we will recruit 16 patients who will be randomly allocated to one of either HBO or PENTOCLO. After a 4 week period of uniform ‘pre-treatment’ medication patients will be commenced on their allocated treatment. Standard follow-up examination, imaging and photographs will be taken and de-identified and then presented to two Oral and Maxillofacial surgeons for allocation of a Notani & Lyons classification score. Data for each patient will be tracked over the 18 months of treatment and follow-up. The results will then be analysed using descriptive statistics and all patients included in an intention to treat analysis. ETHICS AND DISSEMINATION: Ethical approval for this study has been granted by the South Metropolitan Health Service HREC (PRN RGS0000001193). Data generated by conducting this study will be uploaded to an open access repository in a de-identified form. Results from this study will be disseminated at national and international conferences as well as peer reviewed medical publications. TRIAL REGISTRATION NUMBER: ACTRN12618001099213; Pre-results.