The objective of this phase II study was to determine the effectiveness of a mucoadhesive
propolis gel in the prevention of radiation-induced
oral mucositis. Twenty-four patients who were selected to undergo
radiation therapy for
oral cancer were included in this open-label trial. They were advised to use a mucoadhesive gel containing
propolis 5,0% w/v three times a day starting one day before the course of
radiation therapy and concluding after 2 weeks of
radiation therapy. A weekly follow-up for evaluation of food intake,
pain and grading of
mucositis was performed. In order to confirm the absence of Candida-related
mucositis in patients who developed
mucositis, it was performed exfoliative cytology of buccal mucosa, palate and tongue and the material for Candifast(®) Candida species identification. At the end of the study was made the compliance of patients, quality, appreciation and acceptance of product evaluation. Twenty patients did not develop
mucositis, two patients developed grade 1
mucositis and two patients developed grade 2
mucositis. None of the patients discontinued food intake and no
pain was observed during the study. Candidosis was not detected in any patient. Mucoadhesive
propolis gel could be considered as a potential topical medication for preventing radiation-induced
oral mucositis. However, comparative phase III study with larger number of patients should be done for confirmation of the efficacy of the product.