Cryotherapy in the prevention of oral mucositis in patients receiving low-dose methotrexate following myeloablative allogeneic stem cell transplantation: a prospective randomized study of the Gruppo Italiano Trapianto di Midollo Osseo nurses group.

Severe oral mucositis is a major cause of morbidity following allogeneic hematopoietic stem cell transplantation (AHSCT). Cryotherapy, that is, the application of ice chips on the mucosa of the oral cavity during the administration of antineoplastic agents, may reduce the incidence and severity of chemotherapy-related oral mucositis. In this multicenter randomized study, we addressed whether cryotherapy during MTX administration is effective in the prevention of severe oral mucositis in patients undergoing myeloablative AHSCT. One hundred and thirty patients undergoing myeloablative AHSCT and MTX-containing GVHD prophylaxis were enrolled and randomized to receive or not receive cryotherapy during MTX administration. The incidence of severe (grade 3-4) oral mucositis, the primary end point of the study, was comparable in patients receiving or not cryotherapy. Moreover, no difference was observed in the incidence of oral mucositis grade 2-4 and the duration of oral mucositis grade 3-4 or 2-4, or in the kinetics of mucositis over time. In univariate and multivariate analysis, severe oral mucositis correlated with TBI in the conditioning regimen and lack of folinic acid rescue following MTX administration. Thus, cryotherapy during MTX administration does not reduce severe oral mucositis in patients undergoing myeloablative allogeneic HSCT. Future studies will assess cryotherapy before allogeneic HSCT.

Incidence and severity of oral mucositis in patients undergoing haematopoietic SCT--results of a multicentre study.

Oral mucositis (OM) is a common side effect experienced during haematopoietic SCT (HSCT), and it can have a significant impact on the quality of life of patients. A descriptive nurse-led study was undertaken in 19-member centres of the Italian national transplant group (GITMO) evaluating incidence, severity and duration of OM in patients undergoing HSCT. Data from 1841 patients between 2002 and 2006 was analyzed. Initial medical history and oral cavity assessment was performed. Assessment was repeated on the day of transplant, then daily, using the WHO (World Health Organisation) oral toxicity scale. A total of 71% of the patients evaluated developed mucositis and 21.6% developed severe mucositis. Duration of OM in most cases lasted for 10-14 days and resolved along with marrow reconstitution. Oral mucostitis is a frequent side effect in patients undergoing HSCT. The onset of severe mucositis seems to be related to the conditioning regimen used. This database provides a descriptive overview of the incidence and severity of mucositis and has encouraged participating centres to adopt routine evaluation and measurement of the oral cavity. The assessment tools are still used in some centres, providing a basis for further collaborative research projects.