International Journal of Radiation Oncology * Biology * Physics
Volume 51, Issue 3 , Pages 628-635 , 1 November 2001

The effect of oral sucralfate on the acute proctitis associated with prostate radiotherapy: a double-blind, randomized trial

  • Andrew Kneebone (F.R.A.N.Z.C.R.)

      Affiliations

    • Cancer Therapy Centre, Liverpool Hospital, Liverpool, Australia
    • Corresponding Author InformationReprint requests to: Andrew Kneebone, MBBS, F.R.A.N.Z.C.R., Cancer Therapy Centre, Liverpool Hospital, Locked Bag 7103, Liverpool BC 1871, NSW, Australia. Tel: 61 2 9828 5282; Fax: 61 2 9828 5299
    • ,
  • Hedy Mameghan (F.R.A.N.Z.C.R.)

      Affiliations

    • Peter MacCallum Cancer Institute, Melbourne, Australia
    • ,
  • Terry Bolin (FRACP)

      Affiliations

    • Division of Gastroenterology, Westmead Hospital, Australia
    • ,
  • Martin Berry (F.R.A.N.Z.C.R.)

      Affiliations

    • Cancer Therapy Centre, Liverpool Hospital, Liverpool, Australia
    • ,
  • Sandra Turner (F.R.A.N.Z.C.R.)

      Affiliations

    • Department of Radiation Oncology, Westmead Hospital, Australia
    • ,
  • John Kearsley (F.R.A.N.Z.C.R.)

      Affiliations

    • Cancer Care Centre, St. George Hospital, Kogarah, Australia
    • ,
  • Peter Graham (F.R.A.N.Z.C.R.)

      Affiliations

    • Cancer Care Centre, St. George Hospital, Kogarah, Australia
    • ,
  • Richard Fisher, Ph.D.

      Affiliations

    • Peter MacCallum Cancer Institute, Melbourne, Australia
    • Department of Radiation Oncology, Prince of Wales Hospital, Randwick, Australia
    • ,
  • Geoff Delaney (F.R.A.N.Z.C.R.)

      Affiliations

    • Cancer Therapy Centre, Liverpool Hospital, Liverpool, Australia

Received 22 December 2000 ,Revised 30 April 2001 ,Accepted 7 May 2001.

References 

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  3. O’Brien P, Franklin CI, Dear KBG, et al.  A phase III double blind randomised study of rectal sucralfate suspension in the prevention of acute radiation proctitis. Radiother Oncol. 1997;45:117–123
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  9. Szabo S, Hollander D. Pathways of gastrointestinal protection and repair (Mechanism of action of sucralfate). Am J Med. 1989;86:23–31
  10. Tarnawski A, Hollander D, Krause WJ, et al.  Does sucralfate affect the normal gastric mucosa? Histologic, ultrastructural, and functional assessment in the rat. Gastroenterology. 1986;90:893–905
  11. Burch RM, McMillan BA. Sucralfate induces proliferation of dermal fibroblasts and keratinocytes in culture and granulation tissue formation in full thickness skin wounds. Agents Actions. 1991;34:229–231
  12. Henriksson R, Franzen L, Littbrand B. Effects of sucralfate on acute and late bowel discomfort following radiotherapy of pelvic cancer. J Clin Oncol. 1992;10:969–975
  13. Valls A, Algara M, Domenech M, et al.  Efficacy of sucralfate in the prophylaxis of diarrhoea secondary to acute radiation-induced enteritis. Preliminary results of a double blind randomised trial. Med Clin (Barc). 1991;96:449–452
  14. Martenson JA, Bollinger JW, Sloan JA, et al.  Sucralfate in the prevention of treatment induced diarrhea in patients receiving pelvic radiation therapy (A North Central Cancer Treatment Group phase III double-blind placebo controlled trial). J Clin Oncol. 2000;18:1239–1245
  15. Gotzsche PC. Blinding during data analysis and writing of manuscripts. Controlled Clin Trials. 1996;17:285–293
  16. Hochberg Y. A sharper Bonferroni procedure for multiple tests of significance. Biometrika. 1988;75:800–802
  17. Sur RK, Kochhar R, Singh DP. Oral sucralfate in acute radiation oesophagitis. Acta Oncol. 1994;33:61–63
  18. Pfeiffer P, Madsen EL, Hansen O, et al.  Effect of prophylactic sucralfate suspension on stomatitis induced by cancer chemotherapy. A randomised, double-blind crossover study. Acta Oncol. 1990;29:171–173
  19. Maiche A, Isolangas O, Grohn P. Skin protection by sucralfate cream during electron beam therapy. Acta Oncol. 1994;33:201–203
  20. Epstein JB, Wong FLW. The efficacy of sucralfate suspension in the prevention of oral mucositis due to radiation therapy. Int J Radiat Oncol Biol Phys. 1994;28:693–698
  21. Makkonen TA, Bostrom P, Vilja P, et al.  Sucralfate mouth washing in the prevention of radiation-induced mucositis (A placebo-controlled, double-blind randomised study). Int J Radiat Oncol Biol Phys. 1994;30:177–182
  22. Meredith R, Salter M, Kim R, et al.  Sucralfate for radiation mucositis (Results of a double blind randomised trial). Int J Radiat Oncol Biol Phys. 1997;37:275–279
  23. Delaney G, Fisher R, Hook C, et al.  Sucralfate cream in the management of moist desquamation during radiotherapy. Australasian Radiol. 1997;41:270–275
  24. Elsaid A, Elassal S. Sucralfate with pelvic radiotherapy: Sense or nonsense? Abstract 2112; Proceedings of the 40th Annual ASTRO Meeting; 1998.
  25. Lievens Y, Haustermans K, Van den Weyngaert D, et al.  Does sucralfate reduce the acute side effects in head and neck cancer treated with radiotherapy? A double blind randomized trial. Radiother Oncol. 1998;47:149–153
  26. Kochhar R, Patel F, Dhar A, et al.  Radiation-induced proctosigmoiditis. Prospective, randomized, double-blind controlled trial of oral sulfasalazine plus rectal steroids versus rectal sucralfate. Dig Dis Sci. 1991;36:103–107
  27. Franzen L, Henriksson R, Littbrand B, et al.  Effects of sucralfate on mucositis during and following radiotherapy of malignancies in the head and neck region. A double blind placebo controlled study. Acta Oncol. 1995;34:219–223

☆ This study was supported in part by a grant from Chugai Pharmaceuticals, as well as from the Radiation Oncology trust fund from the Prince of Wales Hospital. The investigators maintained complete scientific independence of the trial with respect to its design, conduct, analysis, interpretation, and publication.

PII: S0360-3016(01)01660-1

doi: 10.1016/S0360-3016(01)01660-1

International Journal of Radiation Oncology * Biology * Physics
Volume 51, Issue 3 , Pages 628-635 , 1 November 2001

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