Efficacy of synbiotics to reduce acute radiation proctitis symptoms and improve quality of life: a randomized, double-blind, placebo-controlled pilot trial

Int J Radiat Oncol Biol Phys. 2014 Oct 1;90(2):289-95. doi: 10.1016/j.ijrobp.2014.05.049.

Abstract

Purpose: To evaluate whether the daily intake of synbiotics interferes in radiation-induced acute proctitis symptoms and in quality of life in patients with prostate cancer.

Methods and materials: Twenty patients who underwent 3-dimensional conformal radiation therapy for prostate cancer were randomized to intake either a synbiotic powder containing Lactobacillus reuteri 10(8) colony-forming units and 4.3 g of soluble fiber (Nestlé) or placebo. The questionnaire EORTC QLQ-PRT23 was applied before the beginning of radiation therapy and in every week for the first 4 weeks of treatment. The sum of both the complete (proctitis symptoms plus quality of life) and partial (proctitis symptoms) scores of the EORTC QLQ-PRT23 (European Organization for Research and Treatment of Cancer Quality of Life Module for Proctitis-23 items) questionnaire were the main endpoints.

Results: This pilot study showed that the complete questionnaire score (median [range]) was higher in the second (23 [21-30] vs 26.5 [22-34], P<.05) and third (23 [21-32] vs 27.5 [24-33], P<.01) weeks in the placebo group. Proctitis symptoms were highest scored in the placebo group in both the second (19.5 [16-25]) and third (19 [17-24]) weeks than in the synbiotic group (week 2: 16.5 [15-20], P<.05; week 3: 17 [15-23], P<.01). In both scores the placebo group had a significantly higher result (P<.01) than the synbiotic group (repeated-measures analysis of variance).

Conclusions: Synbiotics reduce proctitis symptoms and improve quality of life in radiation-induced acute proctitis during radiation therapy for prostate cancer.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Acute Disease
  • Aged
  • Analysis of Variance
  • Dietary Fiber / administration & dosage
  • Double-Blind Method
  • Humans
  • Limosilactobacillus reuteri*
  • Male
  • Middle Aged
  • Pilot Projects
  • Proctitis / etiology
  • Proctitis / therapy*
  • Prospective Studies
  • Prostatic Neoplasms / radiotherapy*
  • Quality of Life*
  • Radiation Injuries / therapy*
  • Radiotherapy, Conformal / adverse effects*
  • Surveys and Questionnaires
  • Synbiotics*
  • Time Factors