title: A controlled evaluation of an allopurinol mouthwash as prophylaxis against 5-fluorouracil-induced stomatitis.
abstract: Pursuant to a promising report suggesting that an allopurinol mouthwash could have a protective effect against 5-fluorouracil (5-FU)-induced stomatitis, the authors performed a randomized, placebo-controlled, double-blind, crossover study. Seventy-seven patients, receiving their first 5-day course of chemotherapy with 5-FU +/- leucovorin, were assigned to use a mouthwash containing 20 mg of allopurinol or a placebo. The mouthwash was administered every hour for four doses commencing with each chemotherapy dose. The severity of subsequent mucositis was graded (on a 0-4 scale) by the attending physician and also by a patient-completed questionnaire. There was trend toward less mucositis in the placebo group with mean physician-judged mucositis scores of 1.3 for placebo and 1.8 for allopurinol (P = 0.07) and mean patient-judged mucositis scores of 1.5 for placebo and 1.9 for allopurinol (P = 0.15). There were no substantial differences in mucositis attributable to the two mouthwashes in the patients who crossed-over on their second cycle of chemotherapy. These data demonstrate that the tested allopurinol mouthwash regimen does not offer any protective effect against 5-FU-induced mucositis.
authors.affiliation: Mayo Clinic, Rochester, Minnesota.
authors.forename: C L
authors.initials: CL
authors.lastname: Loprinzi
authors.forename: S G
authors.initials: SG
authors.lastname: Cianflone
authors.forename: A M
authors.initials: AM
authors.lastname: Dose
authors.forename: P S
authors.initials: PS
authors.lastname: Etzell
authors.forename: N L
authors.initials: NL
authors.lastname: Burnham
authors.forename: T M
authors.initials: TM
authors.lastname: Therneau
authors.forename: L
authors.initials: L
authors.lastname: Hagen
authors.forename: D K
authors.initials: DK
authors.lastname: Gainey
authors.forename: M
authors.initials: M
authors.lastname: Cross
authors.forename: L M
authors.initials: LM
authors.lastname: Athmann
mesh_terms: D000493:Allopurinol / Q000008:administration & dosage / Q000627:therapeutic use*; D015179:Colorectal Neoplasms / Q000188:drug therapy; D003258:Consumer Behavior; D004311:Double-Blind Method; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects*; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage / Q000627:therapeutic use; D008875:Middle Aged; D009067:Mouthwashes; D010919:Placebos; D016032:Randomized Controlled Trials as Topic; D013280:Stomatitis / Q000139:chemically induced / Q000517:prevention & control*
chemical_list: D009067:Mouthwashes; D010919:Placebos; D000493:Allopurinol; D002955:Leucovorin; D005472:Fluorouracil