Effective use of a sodium-hyaluronate spray formulation in oral mucositis

Background andaims: Orai mucositis (OM) is one of thè most frequent and potentially severe acute side effect of non-surgical cancer therapy which often leads to significant morbidity, mortality and decreased quality of life. Today a standard and universally accepted management strategy to prevent and treat it does not exist. Given thè key role played by connective damage in its pathogenesis, thè use of a compound which promotes thè extracellular matrix regeneration couìd be a valid therapeutic strategy. In this regard, thè use of hyaluronic acid, that plays an important role in orai lissue healing by means of several mechanisms, has been showed to provide good results in managing OM. The aim of this open clinical trial is to assess thè effects of a spray compound containing a pool of collagen precursor synthetic aminoacids (1-proline, 1-SeucÌne. 1- lysine and giycine) combined with sodium hyaluronate in thè treatment of OM. Materials and methods: Fifty-four patients with OM were consecutively and unseiec- tively recruited. The treatment efficacy was evaluated on (i) pain score, (ii) clinicaì resolution index (CRI) and (iii) WHO Mucositis scale recorded at times TO (baseline). T01 (2 h), TI (24 h), T2 (72 h), T3 (7 days) and T4 (14 days). Results: The application of thè spray showed a significant reduction in paìn after only 2 h compared with baseline measurements (P < 0.0001). A progressive reduction of pain through thè 2 weeks was also noted (P < 0.0001). Patient ìesions treated with thè spray also significantly improved after 72 h of treatment both in terms of CRI (P = 0.0186) and as WHO Mucositis score (P < 0.0001). Conclusions and relevance: Although further studies are recommended. our fìndings confimi that spray formulation may offer rapid and effective paìn management aiding a fast mucosal wound healing with consequent improvement of thè ability to eat anc drink which usually compromises patients suffering from OM.