Daily sodium butyrate enema for the prevention of radiation proctitis in prostate cancer patients undergoing radical radiation therapy: Results of a multicenter randomized placebo-controlled dose-finding phase 2 study

International Journal of Radiation Oncology Biology Physics

Volumn 89, Issue 3, 2014, Pages 518-524

  Maggio, Angelo ^a   Magli, Alessandro ^b   Rancati, Tiziana ^c   Fiorino, Claudio ^a   Valvo, Francesca ^c   Fellin, Giovanni ^d   Ricardi, Umberto ^e   Munoz, Fernando ^f   Cosentino, Dorian ^g   Cazzaniga, Luigi Franco ^g   Valdagni, Riccardo ^c   Vavassori, Vittorio ^h  

^a SAN RAFFAELE HOSPITAL   (Italy)

^b SANTA MARIA DELLA MISERICORDIA UNIVERSITY HOSPITAL   (Italy)

^c NATIONAL CANCER INSTITUTE   (Italy)

^d SANTA CHIARA HOSPITAL   (Italy)

^e UNIVERSITY OF TURIN   (Italy)

^f CITTÀ DELLA SALUTE E DELLA SCIENZA HOSPITAL   (Italy)

^g SANT ANNA HOSPITAL   (Italy)

^h OSPEDALE DI CIRCOLO   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

DISEASES; ENDOSCOPY; SODIUM; TOXICITY; UROLOGY;

ABDOMINAL SURGERY; DAMAGING EFFECTS; HORMONAL THERAPY; METHODS AND MATERIALS; PROSTATE CANCERS; SODIUM BUTYRATE; TOXICITY ENDPOINTS; UNIVARIATE ANALYSIS;

RADIOTHERAPY;

BUTYRIC ACID; ENEMA; NABUMETONE; PLACEBO;

ABDOMINAL SURGERY; ADULT; ARTICLE; CANCER HORMONE THERAPY; CANCER RADIOTHERAPY; COMORBIDITY; CONTROLLED STUDY; DIABETES MELLITUS; EXTERNAL BEAM RADIOTHERAPY; HEMORRHOID; HUMAN; HYPERTENSION; LOGISTIC REGRESSION ANALYSIS; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROCTITIS; PROSTATE CANCER; QUESTIONNAIRE; RADIATION DOSE; RADIATION INJURY; RADIATION ONCOLOGIST; RADIATION PROCTITIS; RANDOMIZED CONTROLLED TRIAL; RECTUM MUCOSA; SELF REPORT; TREATMENT OUTCOME;

ACUTE DISEASE; ADMINISTRATION, RECTAL; ANALYSIS OF VARIANCE; ANTINEOPLASTIC AGENTS, HORMONAL; BUTYRIC ACID; DIABETES COMPLICATIONS; DOUBLE-BLIND METHOD; ENEMA; HEMORRHOIDS; HUMANS; INTESTINAL MUCOSA; MALE; PROCTITIS; PROSTATIC NEOPLASMS; RADIATION INJURIES; RECTUM;

EID: 84902210467     PISSN: 03603016     EISSN: 1879355X     Source Type: Journal    
DOI: 10.1016/j.ijrobp.2014.03.018     Document Type: Article

References (16)

1. V. Vavassori, C. Fiorino, and T. Rancati et al. Predictors for rectal and intestinal acute toxicities during prostate cancer high-dose 3D-CRT: Results of a prospective multicenter study Int J Radiat Oncol Biol Phys 67 2007 1401 1410
2. M.R. Storey, A. Pollack, and G. Zagars et al. Complications from radiotherapy dose escalation in prostate cancer: Preliminary results of a randomized trial Int J Radiat Oncol Biol Phys 48 2000 635 642
3. W.D. Heemsbergen, S.T. Peeters, and P.C. Koper et al. Acute and late gastrointestinal toxicity after radiotherapy in prostate cancer patients: Consequential late damage Int J Radiat Oncol Biol Phys 66 2006 3 10
4. W. Dorr, and J.H. Hendry Consequential late effects in normal tissues Radiother Oncol 61 2001 223 231
5. C. Fiorino, G. Sanguineti, and C. Cozzarini et al. Rectal dose-volume constraints in high-dose conformal radiotherapy for localized prostate cancer Int J Radiat Oncol Biol Phys 57 2003 953 962
6. C. Fiorino, G. Fellin, and T. Rancati et al. Clinical and dosimetric predictors of late syndrome after 3D-CRT for localized prostate cancer: Preliminary results of a multicenter prospective study Int J Radiat Oncol Biol Phys 70 2008 1130 1137
7. K. Rauch, and H. Weiland Therapy of radiogenic colitis with salicylazosulfapyridine (azulfidine) Strahlentherapie 143 1972 660 663
8. S. Szepesi, V. Jacobi, and P. Vecsei et al. Treatment of radiogenic colitis with a rectal foam containing cortisol. Clinical and pharmacologic data Strahlenther Onkol 166 1990 271 274
9. P. Vernia, P.L. Fracasso, and V. Casale et al. Topical butyrate for acute radiation proctitis: Randomised, crossover trial Lancet 356 2000 1232 1235
10. S.T. Peeters, W.D. Heemsbergen, and W.L. Van Putten et al. Acute and late complications after radiotherapy for prostate cancer: Results of a multicentric randomized trial comparing 68 Gy to 78 Gy Int J Radiat Oncol Biol Phys 61 2005 1019 1034
11. P.C. O'Brien, C.I. Franklin, and K.B. Dear et al. A phase III double-blind randomised study of rectal sucralfate suspension in the prevention of acute radiation proctitis Radiother Oncol 45 1997 117 123
12. N. Hovdenak, L.F. Fajardo, and M. Hauer-Jensen Acute radiation proctitis: A sequential clinicopathologic study during pelvic radiotherapy Int J Radiat Oncol Biol Phys 48 2000 1111 1117
13. K.W. Schroeder, W.J. Tremaine, and D.M. Ilstrup Coated oral 5-aminosalicylic acid therapy for mildly to moderately active ulcerative colitis. A randomized study N Engl J Med 317 1987 1625 1629
14. A. Hille, M.K. Herrmann, and T. Kertesz et al. Sodium butyrate enemas in the treatment of acute radiation-induced proctitis in patients with prostate cancer and the impact on late proctitis Strahlenther Onkol 184 2008 686 692
15. M. Crespi, M. Delvaux, and M. Schaprio et al. Working party report by the committee for minimal standards of terminology and documentation in digestive endoscopy of the European Society of Gastrointestinal Endoscopy Am J Gastroenterol 91 1996 191 216
16. E. Ippolito, F. Deodato, and G. Macchia et al. Early radiation-induced mucosal changes evaluated by proctoscopy: Predictive role of dosimetric parameters Radiother Oncol 104 2012 103 108