Sucralfate mouthwash for prevention and treatment of 5-fluorouracil-induced mucositis: a randomized, placebo-controlled trial.

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.
AuthorsMichelle Nottage, Sue-Anne McLachlan, Mary-Anne Brittain, Amit Oza, David Hedley, Ronald Feld, Lillian L Siu, Gregory Pond, Malcolm J Moore
JournalSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer (Support Care Cancer) Vol. 11 Issue 1 Pg. 41-7 (Jan 2003) ISSN: 0941-4355 [Print] Germany
PMID12527953 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial)
Chemical References
  • Anti-Ulcer Agents
  • Antimetabolites, Antineoplastic
  • Mouthwashes
  • Placebos
  • Sucralfate
  • Fluorouracil
  • Administration, Oral
  • Aged
  • Anti-Ulcer Agents (administration & dosage, pharmacology)
  • Antimetabolites, Antineoplastic (adverse effects, therapeutic use)
  • Double-Blind Method
  • Female
  • Fluorouracil (adverse effects, therapeutic use)
  • Humans
  • Male
  • Middle Aged
  • Mouth Mucosa (pathology)
  • Mouthwashes
  • Placebos (administration & dosage)
  • Stomatitis (drug therapy, etiology, prevention & control)
  • Sucralfate (administration & dosage, pharmacology)
  • Treatment Outcome

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