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.
Keywords: Head and neck cancer, mucoadhesive gel, oral mucositis, propolis, radiotherapy.
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