Sucralfate in the treatment of chemotherapy-induced stomatitis: a double-blind, placebo-controlled pilot study.
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.


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.


CONCLUSIONS
In the present pilot study, sucralfate did not demonstrate a significant advantage in comparison to the placebo in the treatment of chemotherapy-induced stomatitis.
Chiara
S
S
Department of Medical Oncology, National Institute for Cancer Research, Genova, Italy. schiara@hp380.ist.unige.it
Nobile
M T
MT
Vincenti
M
M
Gozza
A
A
Pastrone
I
I
Rosso
M
M
Rosso
R
R
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy; D010865:Pilot Projects; D010919:Placebos; D013280:Stomatitis / Q000139:chemically induced / Q000188:drug therapy*; D013392:Sucralfate / Q000627:therapeutic use*
D000897:Anti-Ulcer Agents; D000970:Antineoplastic Agents; D010919:Placebos; D013392:Sucralfate