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Sucralfate mouthwash for prevention and treatment of 5-fluorouracil-induced mucositis: a randomized, placebo-controlled trial.
Support Care Cancer 2003; 11(1):41-7SC

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+Show Affiliations

Department of Medical Oncology, Princess Margaret Hospital, 610 University Ave, Toronto, Ontario M5G 2M9, Canada. Michelle.Nottage@uhn.on.caNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

12527953

Citation

Nottage, Michelle, et al. "Sucralfate Mouthwash for Prevention and Treatment of 5-fluorouracil-induced Mucositis: a Randomized, Placebo-controlled Trial." Supportive Care in Cancer : Official Journal of the Multinational Association of Supportive Care in Cancer, vol. 11, no. 1, 2003, pp. 41-7.
Nottage M, McLachlan SA, Brittain MA, et al. Sucralfate mouthwash for prevention and treatment of 5-fluorouracil-induced mucositis: a randomized, placebo-controlled trial. Support Care Cancer. 2003;11(1):41-7.
Nottage, M., McLachlan, S. A., Brittain, M. A., Oza, A., Hedley, D., Feld, R., ... Moore, M. J. (2003). Sucralfate mouthwash for prevention and treatment of 5-fluorouracil-induced mucositis: a randomized, placebo-controlled trial. Supportive Care in Cancer : Official Journal of the Multinational Association of Supportive Care in Cancer, 11(1), pp. 41-7.
Nottage M, et al. Sucralfate Mouthwash for Prevention and Treatment of 5-fluorouracil-induced Mucositis: a Randomized, Placebo-controlled Trial. Support Care Cancer. 2003;11(1):41-7. PubMed PMID: 12527953.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Sucralfate mouthwash for prevention and treatment of 5-fluorouracil-induced mucositis: a randomized, placebo-controlled trial. AU - Nottage,Michelle, AU - McLachlan,Sue-Anne, AU - Brittain,Mary-Anne, AU - Oza,Amit, AU - Hedley,David, AU - Feld,Ronald, AU - Siu,Lillian L, AU - Pond,Gregory, AU - Moore,Malcolm J, Y1 - 2002/07/23/ PY - 2003/1/16/pubmed PY - 2003/5/7/medline PY - 2003/1/16/entrez SP - 41 EP - 7 JF - Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer JO - Support Care Cancer VL - 11 IS - 1 N2 - 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. SN - 0941-4355 UR - https://www.unboundmedicine.com/medline/citation/12527953/Sucralfate_mouthwash_for_prevention_and_treatment_of_5_fluorouracil_induced_mucositis:_a_randomized_placebo_controlled_trial_ L2 - https://dx.doi.org/10.1007/s00520-002-0378-8 DB - PRIME DP - Unbound Medicine ER -