A randomized double blind placebo controlled multicenter study of mesalazine for the prevention of acute radiation enteritis

Radiotherapy and Oncology

Volumn 44, Issue 1, 1997, Pages 59-63

  Resbeut, Michel ^a   Marteau, Philippe ^g   Cowen, Didier ^a   Richaud, Pierre ^b   Bourdin, Sylvain ^c   Dubois, Jean Bernard ^d   Mere, Pascale ^e   N'Guyen, Tan D ^f  

^a INSTITUT PAOLI CALMETTES   (France)

^b INSTITUT BERGONIÉ   (France)

^c CENTRE RENÉ GAUDUCHEAU   (France)

^d CENTRE VAL D AURELLE   (France)

^e CENTRE LÉON BÉRARD   (France)

^f INSTITUT JEAN GODINOT   (France)

^g Ferring SA   (France)

Author keywords

Acute radiation enteritis; Mesalazine; Pelvic irradiation

Indexed keywords

MESALAZINE; PLACEBO;

ADULT; AGED; ARTICLE; CLINICAL TRIAL; DIARRHEA; DOUBLE BLIND PROCEDURE; ENTERITIS; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PRIORITY JOURNAL; PROSTATE CANCER; RADIATION INJURY; UTERUS CANCER;

ACUTE DISEASE; ADULT; AGED; AMINOSALICYLIC ACIDS; ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; DIARRHEA; DOUBLE-BLIND METHOD; ENTERITIS; FEMALE; HUMANS; MALE; MESALAMINE; MIDDLE AGED; PELVIS; RADIATION INJURIES; RADIOTHERAPY;

EID: 0030739487     PISSN: 01678140     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0167-8140(97)00064-9     Document Type: Article

References (22)

1. Ahnfelt-Ronne, I., Haagen-Nielsen, O., Chirstensen, A., Langholz, E., Binder, V. and Riis, P. Clinical evidence supporting the radical scavenger mechanism of 5-aminosalicylic acid. Gastroenterology 98: 1162-1109, 1990.
2. Baughan, C.A., Canney, P.A., Buchanan, R.B. and Pickering, R.M. A randomized trial to assess the efficacy of 5-aminosalicylic acid for the prevention of radiation enteritis. Clin. Oncol. 5: 19-24, 1993.
3. Bourne, R.G., Kearsley, J.H., Grove, W.D. and Roberts, S. The relationship between early and late gastrointestinal complications of radiation therapy for carcinoma of the cervix. Int. J. Radiat. Oncol. Biol. Phys. 9: 1445-1450, 1983.
4. Gallagher, M.J., Brereton, H.D., Rostock, R.A. et al. A prospective study of treatment techniques to minimize the volume of pelvic small bowel with reduction of acute and late effects associated with pelvic irradiation. Int. J. Radiat. Oncol. Biol. Phys. 12: 1565-1573, 1986.
5. Gallagher, M.J., Brereton, H.D., Rostock, R.A., Roman, D.A. and Roat, D.B. A prospective study of the acute and late small bowel effects in 300 patients receiving pelvic radiation. An update. Int. J. Radiat. Oncol. Biol. Phys. 13, suppl. 1: 195, 1987.
6. Greenfield, S.M., Punchard N.A., Teare, J.P. and Thompson, R.P.H. Review article: the mode of action of the aminosalicylates in inflammatory bowel disease. Aliment. Pharmacol. Ther. 7: 369-383, 1993.
7. Gyrinsky, Th., Rey, A., Roche, B., Haie, Ch., Gerbaulet, A., Randrianarivello, H. and Chassagne, D. Overall treatment time in advanced cervical carcinomas: a critical parameter in treatment outcome. Int. J. Radiat. Oncol. Biol. Phys. 27: 1051-1056, 1993.
8. Herbert, S.H., Curran, W.J., Solin, L.J. et al. Decreasing gastrointestinal morbidity with the use of small bowel contrast during treatment planning for pelvic irradiation. Int. J. Radiat. Oncol. Biol. Phys. 20: 835-842, 1991.
9. Henriksson, R., Franzen, L. and Littbrand, B. Prevention and therapy of radiation-induced bowel discomfort. Scand. J. Gastroenterol. 27 supplement: 7-11, 1992.
10. Kinsella, T.J. and Bloomer, W.D. Tolerance of the intestine to radiation therapy. Surg. Gynecol. Obstet. 151: 273-284, 1980.
11. Layer, P.H., Goebell, H., Keller, J., Dignass, A. and Klotz, U. Delivery and fate of oral mesalamine microgranules within the human small intestine. Gastroenterology 108: 1427-1433, 1995.
12. Marteau, P., Nelet, F., Le Lu, M. and Devaux, C. Adverse events in patients treated with 5-aminosalicylic acid: 1993-1994 pharmacovigilance report for Pentasa in France. Aliment. Pharmacol. Ther. 10: 949-956, 1996.
13. Mantel, N. and Haenszel, W. Chi-square tests with one degree of freedom extensions of Mantel-Haenszel procedure. J. Am. Stat. Assoc. 58: 690-700, 1963.
14. Martenson, J.A., Hyland, G., Moertel, C.G. et al. Olsalazine is contraindicated during pelvic radiation therapy: result of a double blind, randomized trial. Int. J. Radiat. Oncol. Biol. Phys. 35: 299-303, 1996.
15. Mennie, A.T., Dalley, V.M., Dinneen, L.C. and Collier, H.O.J. Treatment of radiation-induced gastrointestinal distress with acetylsalicylate. Lancet 2: 342-343, 1975.
16. Rauch, K. and Weilland, H. Behandlung der radiogenen Koliltis mit Salicylazosulfapyridin (Azulfidine®). Strahlentherapie 143: 660-663, 1972.
17. Rose, P.G., Haltyer, S.A. and Su, C.M. The effect of indomethacin on acute radiation-induced gastrointestinal injury: a morphologic study. J. Surg. Oncol. 49: 231-238, 1992.
18. Salminen, E., Elomaa, I., Minkkinen, J., Vapaatalo, H. and Salminen, S. Preservation of intestinal integrity during radiotherapy using live Lactobacillus acidophilus cultures. Clin. Radiol. 39: 435-437, 1988.
19. 2 in subjects with permanent ileostomy. Gut 27: 1306-1311, 1986.
20. Small, R.E. and Schraa, C.C. Chemistry, pharmacology, pharmaco-kinetics and clinical applications of mesalamine for the treatment of inflammatory bowel disease. Pharmacotherapy 14: 385-398, 1994.
21. Wadworth, A.N. and Fitton, A. Olsalazine: a review of its pharmacodynamic and pharmacokinetic properties and therapeutic potential in inflammatory bowel disease. Drugs 41: 647-664, 1991.
22. Wasserman, T.H. Radiotherapeutic studies with amifostine. Semin. Oncol. 21, suppl. 11: 21-25, 1994.