Dr.ALESSANDRA MAJORANA
University of Brescia, Italy
Title: Clinical efficacy of a medical device in the treatment of chemotherapy-induced oral mucositis in children
Biography
Biography: Dr.ALESSANDRA MAJORANA
Abstract
• Introduction: Oral mucositis (OM) is a severe side effect of anti-cancer therapy, especially in children. It causes a painful inflammatory process, which may have a detrimental effect on quality of life and on therapeutic protocols.\r\nObjectives: The aim was to assess the efficacy of a medical device (Mucosyte ®), respect of placebo, in the treatment of chemotherapy-induced OM in childhood. \r\nMethods: Patients between 5 and 18 years of age undergoing chemotherapy for malignancies diseases with OM grade 1 or 2 were enrolled in this study. They were randomized in group A (treated with Mucosyte ®, 3 mouthwashes/day per 8 days) and group B (treated with placebo, that is an inert water based solution, same dosage). \r\nThe OM scoring was performed at day 1 (diagnosis of OM-T0), after three days of treatment (T1), and at day 8 (T2). Pain was evaluated through the Visual Analogue Scale (VAS) with the same timing of OM measurement. A statistical analysis was performed. \r\nResults: A total of 59 patients were included (28 patients per group). Group A experienced a statistically significative decline of OM just at T2 (p=0.0038) while a statistically significative difference in pain reduction between two groups both at T1 and at T2 (p<0.005) was observed. \r\nConclusions: The present trial demonstrated the efficacy of this medical device (Mucosyte ®) on the treatment of chemotherapy-induced OM in children; in fact, thanks to its barrier effect, it is useful in reducing pain, OM score, burning and erythema. \r\n