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Title: 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

Purpose: To evaluate the efficacy of sodium butyrate enemas (NABUREN) in prostate cancer radiation therapy (RT) in reducing the incidence, severity, and duration of acute RT-induced proctitis. Methods and Materials: 166 patients, randomly allocated to 1 of 4 groups (rectal sodium butyrate 1 g, 2 g, or 4 g daily or placebo), were treated with NABUREN during and 2 weeks after RT. The grade of proctitis was registered in a daily diary. The correlation between NABUREN and proctitis was investigated through χ{sup 2} statistics. The toxicity endpoints considered were as follows: total number of days with grade ≥1 proctitis (≥G1); total number of days with grade ≥2 proctitis (≥G2); ≥G1 and ≥G2 proctitis lasting at least 3 and 5 consecutive days starting from week 4 (≥G1+3d, ≥G2+3d); damaging effects of RT on rectal mucosa as measured by endoscopy. The relationship between endpoints and pretreatment morbidities, hormonal therapy, presence of diabetes or hypertension, abdominal surgery, or hemorrhoids was investigated by univariate analysis. Results: The patients were randomly allocated to the 4 arms. No difference in the distribution of comorbidities among the arms was observed (P>.09). The mean ≥G1 and ≥G2 proctitis were 7.8 and 4.9 for placebo and 8.9 and 4.7 for the NABUREN group, respectively. Nomore » favorable trend in reduction of incidence, severity, and duration of ≥G1 and ≥G2 proctitis was observed with NABUREN use. In univariate analysis, ≥G1+3d toxicity was found to be related to hemorrhoids (P=.008), and a slight correlation was found between ≥G2 proctitis and hormonal therapy (P=.06). The RT effects on rectal mucosa as based on endoscopic assessment were mainly related to diabetes (P<.01). Endoscopy data at 6 week showed no significant difference between the placebo and butyrate arms. The other investigated endpoints were not correlated with any of the clinical risk factors analyzed. Conclusion: There was no evidence of efficacy of NABUREN in reducing the incidence, severity, and duration of acute radiation proctitis. There was a correlation between some endpoints and clinical risk factors.« less
Authors:
 [1] ;  [2] ;  [3] ;  [1] ;  [4] ;  [5] ;  [6] ;  [7] ; ;  [8] ;  [3] ;  [9] ;  [10]
  1. Medical Physics, San Raffaele Scientific Institute, Milan (Italy)
  2. Department of Radiotherapy, Ospedale S. Maria della Misericordia, Udine (Italy)
  3. Prostate Cancer Programme, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (Italy)
  4. Division of Radiation Oncology 1, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (Italy)
  5. Department of Radiotherapy, Ospedale Santa Chiara, Trento (Italy)
  6. University of Turin, Department of Oncology, Torino (Italy)
  7. Radiotherapy Unit, AO Città della Salute e della Scienza di Torino, Torino (Italy)
  8. Ospedale S. Anna, Como (Italy)
  9. (Italy)
  10. Department of Radiotherapy, Ospedale di Circolo, Varese (Italy)
Publication Date:
OSTI Identifier:
22420335
Resource Type:
Journal Article
Resource Relation:
Journal Name: International Journal of Radiation Oncology, Biology and Physics; Journal Volume: 89; Journal Issue: 3; Other Information: Copyright (c) 2014 Elsevier Science B.V., Amsterdam, The Netherlands, All rights reserved.; Country of input: International Atomic Energy Agency (IAEA)
Country of Publication:
United States
Language:
English
Subject:
62 RADIOLOGY AND NUCLEAR MEDICINE; CORRELATIONS; DISEASE INCIDENCE; HORMONES; HYPERTENSION; MUCOUS MEMBRANES; NEOPLASMS; PATIENTS; PROCTITIS; PROSTATE; RADIATION DOSES; RADIOTHERAPY; RECTUM; SURGERY; TOXICITY