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Efficacy of Sucralfate Mouth Wash in Prevention of 5-fluorouracil Induced Oral Mucositis: A Prospective, Randomized, Double-Blind, Controlled Trial.
Nutr Cancer 2016; 68(3):456-63NC

Abstract

Sucralfate has been used for the prevention and treatment of radiotherapy- and chemotherapy-induced stomatitis and mucositis in a number of studies, but the results are contradictory. To answer such discrepancies, the present study was designed to evaluate the efficacy of sucralfate mouthwash in prevention of 5-fluorouracil (5-FU)-induced oral mucositis in patients with gastrointestinal malignancies. Patients with gastrointestinal cancers receiving 5-FU-based chemotherapy regimens were included in this randomized, blinded, controlled trial and were randomly allocated to either sucralfate mouthwash (every 6 h) or placebo. The patients were visited at fifth and tenth day of trial; the presence and severity of oral mucositis and the intensity of pain were assessed. The patients receiving sucralfate experienced lower frequency and severity of mucositis (76% vs. 38.5%, P = 0.005 and 84 vs. 38.5%, P < 0.001, respectively) and less intense pain (2.5 ± 2.2 vs. 5.08 ± 3.82, P = 0.004 and 1.33 ± 0.86 vs. 4.12 ± 3.5, P = 0.001, respectively) compared with the placebo group both at day 5 and day 10. Within the sucralfate group, a decrease in frequency and severity of mucositis was observed throughout the trial period, while in the placebo group no such effect was observed. Sucralfate mouthwash reduced the frequency and severity of 5-FU-induced oral mucositis in patients with gastrointestinal malignancies compared with placebo, indicating its efficacy in the prevention of chemotherapy-induced mucositis.

Authors+Show Affiliations

a Department of Clinical Pharmacy , Faculty of Pharmacy, Mazandaran University of Medical Sciences , Sari , Mazandaran Province , Iran.b Department of Pharmaceutical Sciences , Faculty of Pharmacy, Mazandaran University of Medical Sciences , Sari , Mazandaran Province , Iran.c Department of Hematology and Oncology , Imam Khomeini general hospital, Mazandaran University of Medical Sciences , Sari , Mazandaran Province , Iran.a Department of Clinical Pharmacy , Faculty of Pharmacy, Mazandaran University of Medical Sciences , Sari , Mazandaran Province , Iran.a Department of Clinical Pharmacy , Faculty of Pharmacy, Mazandaran University of Medical Sciences , Sari , Mazandaran Province , Iran.a Department of Clinical Pharmacy , Faculty of Pharmacy, Mazandaran University of Medical Sciences , Sari , Mazandaran Province , Iran. d Department of Clinical Pharmacy , Faculty of Pharmacy, Urmia University of Medical Sciences , Urmia , Iran.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

27007594

Citation

Ala, Shahram, et al. "Efficacy of Sucralfate Mouth Wash in Prevention of 5-fluorouracil Induced Oral Mucositis: a Prospective, Randomized, Double-Blind, Controlled Trial." Nutrition and Cancer, vol. 68, no. 3, 2016, pp. 456-63.
Ala S, Saeedi M, Janbabai G, et al. Efficacy of Sucralfate Mouth Wash in Prevention of 5-fluorouracil Induced Oral Mucositis: A Prospective, Randomized, Double-Blind, Controlled Trial. Nutr Cancer. 2016;68(3):456-63.
Ala, S., Saeedi, M., Janbabai, G., Ganji, R., Azhdari, E., & Shiva, A. (2016). Efficacy of Sucralfate Mouth Wash in Prevention of 5-fluorouracil Induced Oral Mucositis: A Prospective, Randomized, Double-Blind, Controlled Trial. Nutrition and Cancer, 68(3), pp. 456-63. doi:10.1080/01635581.2016.1153666.
Ala S, et al. Efficacy of Sucralfate Mouth Wash in Prevention of 5-fluorouracil Induced Oral Mucositis: a Prospective, Randomized, Double-Blind, Controlled Trial. Nutr Cancer. 2016;68(3):456-63. PubMed PMID: 27007594.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy of Sucralfate Mouth Wash in Prevention of 5-fluorouracil Induced Oral Mucositis: A Prospective, Randomized, Double-Blind, Controlled Trial. AU - Ala,Shahram, AU - Saeedi,Majid, AU - Janbabai,Ghasem, AU - Ganji,Reza, AU - Azhdari,Elham, AU - Shiva,Afshin, Y1 - 2016/03/23/ PY - 2016/3/24/entrez PY - 2016/3/24/pubmed PY - 2017/1/14/medline SP - 456 EP - 63 JF - Nutrition and cancer JO - Nutr Cancer VL - 68 IS - 3 N2 - Sucralfate has been used for the prevention and treatment of radiotherapy- and chemotherapy-induced stomatitis and mucositis in a number of studies, but the results are contradictory. To answer such discrepancies, the present study was designed to evaluate the efficacy of sucralfate mouthwash in prevention of 5-fluorouracil (5-FU)-induced oral mucositis in patients with gastrointestinal malignancies. Patients with gastrointestinal cancers receiving 5-FU-based chemotherapy regimens were included in this randomized, blinded, controlled trial and were randomly allocated to either sucralfate mouthwash (every 6 h) or placebo. The patients were visited at fifth and tenth day of trial; the presence and severity of oral mucositis and the intensity of pain were assessed. The patients receiving sucralfate experienced lower frequency and severity of mucositis (76% vs. 38.5%, P = 0.005 and 84 vs. 38.5%, P < 0.001, respectively) and less intense pain (2.5 ± 2.2 vs. 5.08 ± 3.82, P = 0.004 and 1.33 ± 0.86 vs. 4.12 ± 3.5, P = 0.001, respectively) compared with the placebo group both at day 5 and day 10. Within the sucralfate group, a decrease in frequency and severity of mucositis was observed throughout the trial period, while in the placebo group no such effect was observed. Sucralfate mouthwash reduced the frequency and severity of 5-FU-induced oral mucositis in patients with gastrointestinal malignancies compared with placebo, indicating its efficacy in the prevention of chemotherapy-induced mucositis. SN - 1532-7914 UR - https://www.unboundmedicine.com/medline/citation/27007594/Efficacy_of_Sucralfate_Mouth_Wash_in_Prevention_of_5_fluorouracil_Induced_Oral_Mucositis:_A_Prospective_Randomized_Double_Blind_Controlled_Trial_ L2 - http://www.tandfonline.com/doi/full/10.1080/01635581.2016.1153666 DB - PRIME DP - Unbound Medicine ER -