title: Efficacy of Sucralfate Mouth Wash in Prevention of 5-fluorouracil Induced Oral Mucositis: A Prospective, Randomized, Double-Blind, Controlled Trial.
abstract: Sucralfate has been used for the prevention and treatment of radiotherapy- and chemotherapy-induced 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 = 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 = 0.004 and 1.33 ± 0.86 vs. 4.12 ± 3.5, P = 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.
authors.affiliation: a Department of Clinical Pharmacy , Faculty of Pharmacy, Mazandaran University of Medical Sciences , Sari , Mazandaran Province , Iran.
authors.forename: Shahram
authors.initials: S
authors.lastname: Ala
authors.affiliation: b Department of Pharmaceutical Sciences , Faculty of Pharmacy, Mazandaran University of Medical Sciences , Sari , Mazandaran Province , Iran.
authors.forename: Majid
authors.initials: M
authors.lastname: Saeedi
authors.affiliation: c Department of Hematology and Oncology , Imam Khomeini general hospital, Mazandaran University of Medical Sciences , Sari , Mazandaran Province , Iran.
authors.forename: Ghasem
authors.initials: G
authors.lastname: Janbabai
authors.affiliation: a Department of Clinical Pharmacy , Faculty of Pharmacy, Mazandaran University of Medical Sciences , Sari , Mazandaran Province , Iran.
authors.forename: Reza
authors.initials: R
authors.lastname: Ganji
authors.affiliation: a Department of Clinical Pharmacy , Faculty of Pharmacy, Mazandaran University of Medical Sciences , Sari , Mazandaran Province , Iran.
authors.forename: Elham
authors.initials: E
authors.lastname: Azhdari
authors.affiliation: a Department of Clinical Pharmacy , Faculty of Pharmacy, Mazandaran University of Medical Sciences , Sari , Mazandaran Province , Iran.|d Department of Clinical Pharmacy , Faculty of Pharmacy, Urmia University of Medical Sciences , Urmia , Iran.
authors.forename: Afshin
authors.initials: A
authors.lastname: Shiva
mesh_terms: D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D005770:Gastrointestinal Neoplasms / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009067:Mouthwashes / Q000627:therapeutic use*; D010919:Placebos; D013280:Stomatitis / Q000139:chemically induced / Q000517:prevention & control*; D013392:Sucralfate / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000964:Antimetabolites, Antineoplastic; D009067:Mouthwashes; D010919:Placebos; D013392:Sucralfate; D005472:Fluorouracil