Castagna, L., Benhamou, E., Pedraza, E., Luboinski, M., Forni, M., Brandes, I., … Dietrich, P.-Y. (2001). Prevention of mucositis in bone marrow transplantation: A double blind randomised controlled trial of sucralfate. Annals of Oncology, 12, 953–955.

To compare placebo to sucralfate for prevention of mucositis in high-dose chemotherapy and bone marrow transplant (BMT)

Treatment was started one day before the regimen. Patients received one 2 g dose pack every three hours during the day and once during the night if awakened for a maximum of 7 per 24 hours until bone marrow (BM) recovery or end of mucositis.

The study reported on 102 patients hospitalized for allogeneic or autologous BMT.

The study was conducted between April 1991 and November 1993.

This was a prospective, randomized, double-blind study.

Patients were examined twice weekly by two physicians only, recorded prospectively, according to adapted Oral and Maxillofacial Surgeon (OMS) criteria for grafted patients.

• Slightly less patients in the sucralfate group (84%) experienced any grade mucositis compared to placebo (88%).
• Incidence of grade 3-4 mucositis was lower in the sucralfate group (29%) versus placebo (47%) (p = 0.07).
• The rate of severe mucositis was decreased possibly because of mechanical mouth rinses.
• When adjusted for total body irradiation (TBI), the p value for frequency of grade 3–4 mucositis in patients who received sucralfate versus placebo was 0.06.

• Long-term administration of sucralfate was not possible in this patient population because of nausea and vomiting.
• This study was conducted more than 20 years ago.
• The summary claims effectiveness for oral and intestinal mucositis; however, data does not support this claim.