Anticancer research · 2001
Sucralfate in the treatment of chemotherapy-induced stomatitis: a double-blind, placebo-controlled pilot study.
Клиническое исследованиеСтатьяРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Chiara S, Nobile M T, Vincenti M, Gozza A, Pastrone I, Rosso M, Rosso R
Аннотация
BACKGROUND: The study was a double-blind, placebo-controlled, randomised pilot study to assess the efficacy of sucralfate gel in the treatment of chemotherapy-induced mucositis.
PATIENTS AND METHODS: At the onset of stomatitis, forty patients received sucralfate gel (1 gr.) or placebo and were instructed to apply the gel over oral mucosas, 3 times daily.
RESULTS: Objective response was observed in 14 patients (11 complete response+3 partial response) and in 15 patients (10 CR+5 PR), in the sucralfate and placebo arms, respectively; (p = NS). Analysis of VAS (visual analogue scale) scoring of pain did not detect any statistical difference between the two groups. No important side-effects were observed. Twelve out 21 patients who obtained a complete resolution of stomatitis (5 out of 11 and 7 out of 10 in the sucralfate and in placebo arms, respectively) received further treatment at the subsequent course of chemotherapy; prevention of mucositis was observed in 4 patients in the sucralfate arm and in 6 patients in the placebo arm, respectively.
CONCLUSION: In the present pilot study, sucralfate did not demonstrate a significant advantage in comparison to the placebo in the treatment of chemotherapy-induced stomatitis.
PATIENTS AND METHODS: At the onset of stomatitis, forty patients received sucralfate gel (1 gr.) or placebo and were instructed to apply the gel over oral mucosas, 3 times daily.
RESULTS: Objective response was observed in 14 patients (11 complete response+3 partial response) and in 15 patients (10 CR+5 PR), in the sucralfate and placebo arms, respectively; (p = NS). Analysis of VAS (visual analogue scale) scoring of pain did not detect any statistical difference between the two groups. No important side-effects were observed. Twelve out 21 patients who obtained a complete resolution of stomatitis (5 out of 11 and 7 out of 10 in the sucralfate and in placebo arms, respectively) received further treatment at the subsequent course of chemotherapy; prevention of mucositis was observed in 4 patients in the sucralfate arm and in 6 patients in the placebo arm, respectively.
CONCLUSION: In the present pilot study, sucralfate did not demonstrate a significant advantage in comparison to the placebo in the treatment of chemotherapy-induced stomatitis.