Administration of Samital? in children with oral mucositis: a feasibility study

OBJECTIVE: SAMITAL (R), a botan-ical drug containing three highly standardized extracts (Vaccinium myrtillus, Macleaya cordata and Echinacea angustifolia), has shown promis-ing results in treating or preventing oral muco-sitis (OM) in adult patients, but it has not been fully investigated in children. In this study, we assessed the feasibility of SAMITAL administra-tion in pediatric patients receiving anticancer treatment to prevent or treat OM, focusing on identifying an appropriate dose and evaluating safety and tolerability and palatability and treat-ment compliance.PATIENTS AND METHODS: We conducted an open-label, monocentric, prospective study on 18 children receiving anticancer therapy to prevent or treat OM.RESULTS: No SAMITAL (R)-related side effects were observed or reported during the study; moreover, no systemic absorption of SAMITAL (R) metabolites was detected in the bloodstream. However, compliance to SAMITAL (R) was unsat-isfactory and variable (from 2 to 100%), and pa-tients reported low palatability (median taste of 4.8; range 1.0-8.0).CONCLUSIONS: SAMITAL (R) administration appears to be safe in the pediatric population, as it is not absorbed in the bloodstream and does not cause any local or systemic side ef-fects. However, the current formulation is only partially suitable for children, and future studies on SAMITAL (R) in children would need an adapted formulation to increase compliance.