Abstract | PURPOSE: PATIENTS AND METHODS: A phase III, double-blind, placebo-controlled clinical trial was designed. Patients were entered onto the study at the time of the first cycle of 5FU-based chemotherapy. All patients received oral cryotherapy for 30 minutes with each dose of 5FU. In addition, each patient was randomized to receive either a sucralfate solution or a placebo solution to be used if they developed mouth tenderness or mouth sores. The study solution was to be used four times daily for 7 days starting on the first day of mouth tenderness or mouth sores. Stomatitis scores were determined by health care providers and by patients themselves. RESULTS: There was a total of 131 assessable patients entered onto this trial, 50 of whom developed mucositis and used the study medication (27 sucralfate and 23 placebo). There was no suggestion of any difference in stomatitis severity or duration on either protocol arm. CONCLUSION: The resultant data from this clinical trial did not support the prestudy hypothesis that sucralfate would be beneficial for the treatment of 5FU-induced stomatitis.
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Authors | C L Loprinzi, C Ghosh, J Camoriano, J Sloan, P D Steen, J C Michalak, P L Schaefer, P J Novotny, J B Gerstner, D F White, A K Hatfield, S K Quella |
Journal | Journal of clinical oncology : official journal of the American Society of Clinical Oncology
(J Clin Oncol)
Vol. 15
Issue 3
Pg. 1235-8
(Mar 1997)
ISSN: 0732-183X [Print] United States |
PMID | 9060567
(Publication Type: Clinical Trial, Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)
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Chemical References |
- Anti-Ulcer Agents
- Antimetabolites, Antineoplastic
- Sucralfate
- Fluorouracil
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Topics |
- Anti-Ulcer Agents
(therapeutic use)
- Antimetabolites, Antineoplastic
(adverse effects)
- Double-Blind Method
- Fluorouracil
(adverse effects)
- Humans
- Prospective Studies
- Stomatitis
(chemically induced, drug therapy)
- Sucralfate
(therapeutic use)
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