Assessing the effectiveness of Gelclair® in the prevention and therapy of stomatitis in patients undergoing hematopoietic stem-cell transplantation: a randomized trial

Abstract

Chemotherapy-induced stomatitis is a major side effect of the treatment. Numerous approaches are described in the literature for the prevention and treatment of this complication. the aim was assess the effectiveness of Gelclair® in patients undergoing hematopoietic stem-cell transplantation in terms of reducing the incidence of stomatitis, stomatitis-pain and the severity of stomatitis Fifty-seven patients (28 control group and 29 experimental group) used a mouthwash 3 times a day and were evaluated by means of a specially-tailored form containing the following assessment items:stomatitis evaluation scale (WHO), VAS for pain and Likert-Scale for agreement. 61% of patients presented with stomatitis. No difference was observed between the two groups with regard to stomatitis grade throughout the observation period. Painful symptoms were observed in 54% subjects. No differences were observed in terms of average pain perception before the use of mouthwashes throughout the period of observation p=0.06. RESULTS showed a pain-relieving effect in the experimental group after using the mouthwash p=0.04. Although Gelclair® had no influence on the onset and severity of stomatitis in transplanted patients, a significant benefit was observed in terms of pain control. Our study suggest the possibility to implementation the use of Gelclair® in clinical practice. However, further multicenter trials are needed to provide stronger evidence on the real usefulness of this product.