Efficacy of Sucralfate Mouth Wash in Prevention of 5-fluorouracil Induced Oral Mucositis: A Prospective, Randomized, Double-Blind, Controlled Trial

Sucralfate has been used for the prevention and treatment of radiotherapy- and chemotherapyinduced stomatitis and mucositis in a number of studies, but the results are contradictory. To
answer such discrepancies, the present study was designed to evaluate the efficacy of sucralfate
mouthwash in prevention of 5-fluorouracil (5-FU)-induced oral mucositis in patients with
gastrointestinal malignancies. Patients with gastrointestinal cancers receiving 5-FU-based
chemotherapy regimens were included in this randomized, blinded, controlled trial and were
randomly allocated to either sucralfate mouthwash (every 6 h) or placebo. The patients were visited
at fifth and tenth day of trial; the presence and severity of oral mucositis and the intensity of pain
were assessed. The patients receiving sucralfate experienced lower frequency and severity of
mucositis (76% vs. 38.5%, P D 0.005 and 84 vs. 38.5%, P < 0.001, respectively) and less intense pain
(2.5 § 2.2 vs. 5.08 § 3.82, P D 0.004 and 1.33 § 0.86 vs. 4.12 § 3.5, P D 0.001, respectively)
compared with the placebo group both at day 5 and day 10. Within the sucralfate group, a decrease
in frequency and severity of mucositis was observed throughout the trial period, while in the
placebo group no such effect was observed. Sucralfate mouthwash reduced the frequency and
severity of 5-FU-induced oral mucositis in patients with gastrointestinal malignancies compared
with placebo, indicating its efficacy in the prevention of chemotherapy-induced mucositis.