摘要

Background &aims: Radical radiation therapy is commonly used for treatment of pelvic cancer. Up to 80% of patients receiving radiotherapy will develop acute radiation induced diarrhea. The primary aim of this randomized double blind controlled trial is to evaluate the effect of the probiotic Bifilact on moderate and severe treatment-induced diarrhea during pelvic radiation. Methods: Patients with pelvic cancers were treated between 2006 and 2010 at L'Heitel-Dieu de Quebec, University Health Center. Some patients had surgery before pelvic radiotherapy and some received chemotherapy. A total of 246 Patients were randomized between a placebo and either of two regiments of double strain Bifilact probiotics (Lactobacillus acidophilus LAC-361 and Bifidobacterium longum BB536): a standard dose twice a day (1.3 billion CFU) or a high dose three times a day (10 billion CFU). Patients were trained to record their digestive symptoms daily with a standardized scale and they met a registered dietician and radiation oncologist every week during treatment. The main analysis compared time to first appearance of grade >= 2-3-4 diarrhea using Kaplan-Meier curves as measured by proportion of patients without moderate and severe diarrhea. Results: 229 patients were analyzed. The difference between the groups for overall grade 2-3-4 diarrhea was not statistically significant (p = 0.13). However at 60 days, the proportion of patients without moderate and severe diarrhea in the standard dose group (35%) was more than twice as high as that of the placebo group (17%) with a hazard ratio of 0.69 (p = 0.04). In patients who had surgery, the standard probiotics dose group had a better proportion of patients without very severe diarrhea than the placebo group, respectively 97% and 74% (p = 0.03). In all groups, the average number of bowel movements per day during treatment was less than 3 soft stools (p = 0.80) and the median abdominal pain less than 1 based on the National Cancer Institute scale (p = 0.23). Conclusion: Standard dose of Bifilact may reduce radiation induced grade 2-3-4 diarrhea at the end of the treatment of patients with pelvic cancer. In patients operated on before RI, a standard dose of probiotics may reduce radiation induced grade 4 diarrhea. Nutritional interventions by a registered dietician seemed to reduce global digestive symptoms.

  • 出版日期2014-10