title: Sucralfate mouthwash for prevention and treatment of 5-fluorouracil-induced mucositis: a randomized, placebo-controlled trial.
abstract: A randomized, double-blind, placebo-controlled trial was conducted to evaluate the effectiveness of a sucralfate mouthwash in preventing and alleviating oral mucositis induced by 5-fluorouracil (5FU). A total of 81 patients with colorectal cancer were enrolled. Patients were studied during their first cycle of chemotherapy with 5FU and leucovorin (LV) daily for 5 days every 4 weeks (Mayo Clinic schedule). Patients were randomly allocated to receive either a sucralfate suspension or a placebo suspension that was identical in appearance. Patients were instructed to use the suspension as a mouthwash four times daily from the beginning of the chemotherapy cycle. All patients received oral cryotherapy. Patients graded the severity of their own symptoms on a daily basis, and this was the primary outcome measure. There was no difference in the frequency or severity of oral mucositis between the sucralfate- and the placebo-treated group. Some mucositis was reported by 79% of the patient group. Assessment of mucositis by trial staff underestimated the incidence of this problem. Results of this trial do not support the hypothesis that a sucralfate mouthwash can prevent or alleviate oral mucositis induced by 5FU. Patient reporting of mucositis is a more sensitive instrument for assessment of mucositis than review by medical staff.
authors.affiliation: Department of Medical Oncology, Princess Margaret Hospital, 610 University Ave, Toronto, Ontario M5G 2M9, Canada. Michelle.Nottage@uhn.on.ca
authors.forename: Michelle
authors.initials: M
authors.lastname: Nottage
authors.forename: Sue-Anne
authors.initials: SA
authors.lastname: McLachlan
authors.forename: Mary-Anne
authors.initials: MA
authors.lastname: Brittain
authors.forename: Amit
authors.initials: A
authors.lastname: Oza
authors.forename: David
authors.initials: D
authors.lastname: Hedley
authors.forename: Ronald
authors.initials: R
authors.lastname: Feld
authors.forename: Lillian L
authors.initials: LL
authors.lastname: Siu
authors.forename: Gregory
authors.initials: G
authors.lastname: Pond
authors.forename: Malcolm J
authors.initials: MJ
authors.lastname: Moore
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000897:Anti-Ulcer Agents / Q000008:administration & dosage / Q000494:pharmacology*; D000964:Antimetabolites, Antineoplastic / Q000009:adverse effects* / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D005472:Fluorouracil / Q000009:adverse effects* / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D009061:Mouth Mucosa / Q000473:pathology; D009067:Mouthwashes; D010919:Placebos / Q000008:administration & dosage; D013280:Stomatitis / Q000188:drug therapy* / Q000209:etiology / Q000517:prevention & control; D013392:Sucralfate / Q000008:administration & dosage / Q000494:pharmacology*; D016896:Treatment Outcome
chemical_list: D000897:Anti-Ulcer Agents; D000964:Antimetabolites, Antineoplastic; D009067:Mouthwashes; D010919:Placebos; D013392:Sucralfate; D005472:Fluorouracil