Phase III controlled evaluation of sucralfate to alleviate stomatitis in patients receiving fluorouracil-based chemotherapy

Charles Lawrence Loprinzi, C. Ghosh, John K Camoriano, Jeff A 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

Research output: Contribution to journalArticle

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Abstract

Purpose: Stomatitis is a major dose-limiting toxicity of bolus fluorouracil (5FU)-based chemotherapy regimens, despite the use of oral cryotherapy. Pursuant to preliminary data that suggested a sucralfate oral solution could alleviate chemotherapy-induced oral mucositis, we developed a prospective trial to test this contention. 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.

Original languageEnglish (US)
Pages (from-to)1235-1238
Number of pages4
JournalJournal of Clinical Oncology
Volume15
Issue number3
StatePublished - Mar 1997

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Sucralfate
Stomatitis
Fluorouracil
Drug Therapy
Mouth
Cryotherapy
Placebos
Mucositis
Controlled Clinical Trials
Health Personnel
Arm
Clinical Trials

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Phase III controlled evaluation of sucralfate to alleviate stomatitis in patients receiving fluorouracil-based chemotherapy. / Loprinzi, Charles Lawrence; Ghosh, C.; Camoriano, John K; Sloan, Jeff A; Steen, P. D.; Michalak, J. C.; Schaefer, P. L.; Novotny, P. J.; Gerstner, J. B.; White, D. F.; Hatfield, A. K.; Quella, S. K.

In: Journal of Clinical Oncology, Vol. 15, No. 3, 03.1997, p. 1235-1238.

Research output: Contribution to journalArticle

Loprinzi, CL, Ghosh, C, Camoriano, JK, Sloan, JA, Steen, PD, Michalak, JC, Schaefer, PL, Novotny, PJ, Gerstner, JB, White, DF, Hatfield, AK & Quella, SK 1997, 'Phase III controlled evaluation of sucralfate to alleviate stomatitis in patients receiving fluorouracil-based chemotherapy', Journal of Clinical Oncology, vol. 15, no. 3, pp. 1235-1238.
Loprinzi, Charles Lawrence ; Ghosh, C. ; Camoriano, John K ; Sloan, Jeff A ; Steen, P. D. ; Michalak, J. C. ; Schaefer, P. L. ; Novotny, P. J. ; Gerstner, J. B. ; White, D. F. ; Hatfield, A. K. ; Quella, S. K. / Phase III controlled evaluation of sucralfate to alleviate stomatitis in patients receiving fluorouracil-based chemotherapy. In: Journal of Clinical Oncology. 1997 ; Vol. 15, No. 3. pp. 1235-1238.
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AU - Ghosh, C.

AU - Camoriano, John K

AU - Sloan, Jeff A

AU - Steen, P. D.

AU - Michalak, J. C.

AU - Schaefer, P. L.

AU - Novotny, P. J.

AU - Gerstner, J. B.

AU - White, D. F.

AU - Hatfield, A. K.

AU - Quella, S. K.

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N2 - Purpose: Stomatitis is a major dose-limiting toxicity of bolus fluorouracil (5FU)-based chemotherapy regimens, despite the use of oral cryotherapy. Pursuant to preliminary data that suggested a sucralfate oral solution could alleviate chemotherapy-induced oral mucositis, we developed a prospective trial to test this contention. 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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