Efficacy of topical phenytoin on chemotherapy-induced oral mucositis; a pilot study

BACKGROUND AND THE PURPOSE OF THE STUDY: Oral mucositis is one of the most common complications of malignancy chemotherapy. As yet, no absolute treatment has been demonstrated to be effective for chemotherapy-induced oral mucositis. This study evaluates the effectiveness of phenytoin mouthwash as a wound healing agent, on the basis of stimulating effects on fibroblast proliferation. MATERIALS AND METHODS: In this multicenter, randomized, placebo-controlled clinical trial; twelve patients received phenytoin mouthwash (0.5%) or placebo for about two weeks. Oral pain severity was scored on the daily basis using a VAS (visual analogue scale) of 10 centimeters. National Cancer Institute (NCI) scale was used to grade the intensity of mucositis. To determine the effect of treatment, a quality of life questionnaire, consisting of 35 queries, was filled out for all patients. Statistical analyses of data was performed using Mann-Whitney test. RESULTS: The average time for complete remission of mucositis in phenytoin-treated group was less than that of the placebo group. The quality of life improved dramatically in the phenytoin group with the healing process being more evident in the first week. Furthermore, reduction in the wound area was greater in the phenytoin group than controls at the end of the first week of treatment. Both groups eventually demonstrated reduction in pain intensity; however no statistically significant difference was observed between two groups. CONCLUSION: Phenytoin mouthwash accelerated wound healing and resolution of mucositis and improved life quality impressively.