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.
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Authors | Michelle Nottage, Sue-Anne McLachlan, Mary-Anne Brittain, Amit Oza, David Hedley, Ronald Feld, Lillian L Siu, Gregory Pond, Malcolm J Moore |
Journal | Supportive 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 |
PMID | 12527953
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial)
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Chemical References |
- Anti-Ulcer Agents
- Antimetabolites, Antineoplastic
- Mouthwashes
- Placebos
- Sucralfate
- Fluorouracil
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Topics |
- 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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