Fuccio, L., Guido, A., Laterza, L., Eusebi, L.H., Busutti, L., Bunkheila, F., . . . Bazzoli, F. (2011). Randomised clinical trial: Preventive treatment with topical rectal beclomethasone dipropionate reduces post-radiation risk of bleeding in patients irradiated for prostate cancer. Alimentary Pharmacology & Therapeutics, 34(6), 628–637. 

To determine the effectiveness of topical rectal beclomethasone dipropionate (BDP) in the prevention of rectal proctopathy, which can lead to rectal bleeding, in patients undergoing radiation therapy for prostate cancer

The treatment arm consisted of a 3 mg BDP enema each evening before radiotherapy treatments and two 3 mg BDP suppositories (one in the morning and one in the evening daily) over four weeks. The placebo arm consisted of an identical looking enema and suppository given at the same intervals without medication. Time points for clinical evaluation were before radiotherapy, one month after completion of the treatment, and every three months thereafter. Time points for endoscopic evaluation were before treatment, at three months, and at 12 months postradiotherapy. The patients self-administered the treatment, and they were asked to hold the medication in for as long as they could and return the unused materials at the end of the study to assess compliance.

• N = 110  
• AGE = Not collected
• MALES: 100%         
• KEY DISEASE CHARACTERISTICS: Prostate cancer 
• OTHER KEY SAMPLE CHARACTERISTICS: N/A

• SITE: Single-site
• SETTING TYPE: Not specified  
• LOCATION: S.Orsola-Malpighi University Hospital in Italy

• PHASE OF CARE: Active treatment 
• APPLICATIONS: Elder care 

Double-blind, placebo-controlled, randomized trial

• The endoscopic evaluation consisted of a flexible sigmoidoscopy procedure. The findings were measured using World Organisation of Digestive Endoscopy language and were evaluated using the Vienna Rectoscopy Score (VRS).
• Simple Clinical Colitis Activity Index (SCCAI)
• Radiation Therapy Oncology Group and European Organization for Research and Treatment of Cancer acute and late toxicity scales (RTOG/EORTC)
• Inflammatory Bowel Disease Questionnaire quality of life Index (IBDQ)

With respect to bleeding rate, the BDP group showed a statistically significant lower amount of blood in stools (OR = 0.38; 95% CI 0.17–0.86). The patients in the BDP arm showed a later onset of blood in stools overall (p = 0.032). The quality of life IBDQ score was significantly lower in patients randomized to BDP who reported rectal bleeding (p < 0.001). Severe hemorrhagic proctopathy, defined as anemia with a drop in hemoglobin of at least 1.5 g/dL, was found in 10 patients (four in the BDP group and six in the placebo group).

The BDP therapy arm of this study seemed to fair better with respect to bleeding risk postradiation and the prevention of some of the mucosal changes that lead to significant complications. It does not seem to affect other quality of life issues like continence and diarrhea. Changing the formulation of the BDP and/or its frequency of usage may improve outcomes for patients. Since the treatment did not cause harm to patients, it seems to be a good recommendation for patients to try.

It would be best for nurses to train patients on the usage of BDP during and following radiation therapy. A nursing study to evaluate methods of application and quality of life for patients would be the next step to further improve this research.