Annals of Oncology 12:953-955, 2001
© 2001 European Society for Medical Oncology
research-article |
Prevention of mucositis in bone marrow transplantation: A double blind randomised controlled trial of sucralfate
1Department of Haematology BMT Unit
2Btostatistics Institut Gustave Roussy Villejuif France
3Division of Oncology, University Hospital Geneva, Switzerland
4Present address: OncologvHematology Department, Istituto Clinico Hunianitas Rozzano (Ml) Italy
Pierre-Yves Dietrich, MD Hôpital Universitaire Division d'Oncologie 1211 Genéve 14 Switzerland E-mail:pierre-yves.dietrich{at}hcuge.ch
Mucositis is still a leading side effect of high dose chemotherapy and irradiation delivered in autologous and allogeneic bone marrow transplantation. In this double blind randomised study, we tested the efficacy of sucralfate 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 more 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 irradiation (TBI) (P = 0.06), the sole stratification parameter. Interestingly, patients receiving sucralfate showed a significant reduction of diarrhoea (25% vs. 53%, P = 0.005). Overall, the preventive administration of sucralfate appears to be an effective proce dure to diminish the occurrence of severe oral and intestinal mucositis in patients treated by high dose chemotherapy alone or combined with TBI before bone marrow transplantation.
mucositis, stem-cell transplantation, sucralfate
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