Prevention of mucositis in bone marrow transplantation: A double blind randomised controlled trial of sucralfate

Mucositis is still a leading side effect of high dose chemotherapy and irra diation delivered in autologous and allogeneic bone marrow transplantation. In this double blind randomised study, we tested the efficacy of sucralfat e for the prevention of mucositis induced by such conditioning treatments. Treatment was started one day before conditioning regimen and patients were prospectively evaluated. The main endpoint was severe mucositis that was m ore frequent in the placebo group than in the sucralfate group (47% vs. 29% , P = 0.07). This trend was confirmed after adjustment on total body irradi ation (TBI) (P = 0.06), the sole stratification parameter. Interestingly, p atients receiving sucralfate showed a significant reduction of diarrhoea (2 5% vs. 53%, P = 0.005). Overall, the preventive administration of sucralfat e appears to be an effective procedure to diminish the occurrence of severe oral and intestinal mucositis in patients treated by high dose chemotherap y alone or combined with TBI before bone marrow transplantation.