Clinical Trial: Efficacy of Symbiotic in the Reduction of Acute Radiation Proctitis Symptoms
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Efficacy of Symbiotic in the Reduction of Acute Radiation Proctitis Symptoms. A Randomized, Double-blind, Placebo-controlled Trial
Brief Summary: Radiation proctitis is quite common in treatment of pelvic tumors. We investigated whether the use of symbiotic would prevent early symptoms of radiation proctitis and improve the quality of life in patients undergoing radiotherapy for prostate cancer treatment. We randomized patients to intake one sachet of either a symbiotic product containing 4.3 g of dietary fiber and Lactobacillus reuteri in a concentration greater than 10(8)colony forming units (CFU)(Fibermais Flora Nestlé Brazil) or sachets containing 5 g of maltodextrin. They were instructed to dilute one sachet in 200mL of water and drink once a day during the week before the beginning of radiotherapy sessions, and increase the dose to two sachets daily after the beginning of the sessions for four weeks. Every week a questionnaire named EORTC QLQ-PRT23 was applied to evaluate GI symptoms and quality of life.
Detailed Summary:
This is a prospective randomized, double-blind, placebo-controlled trial. The study included consecutively 20 patients referred for treatment of prostate cancer using three-dimensional conformal radiotherapy (3D-RCT). All patients who agreed to participate signed an informed consent form. The exclusion criteria used in this study were: a patient's refusal to participate in the research and history of surgery involving the rectum or inflammatory bowel disease Patients were randomly assigned to receive sachets containing either a symbiotic product in powder form containing 4.3 g of dietary fiber and Lactobacillus reuteri in a concentration greater than 1.0 x 108 colony forming units (CFU), with five grams per sachet (Fibermais Flora Nestlé Brazil) (symbiotic group) or maltodextrin (5g) with identical casing and identical aspect of the symbiotic group. All subjects were instructed to dilute one sachet in a glass of water and drink once a day during the week before the beginning of radiotherapy sessions, increasing the dose to two sachets daily after the beginning of the sessions.
EORTC QLQ-PRT23 questionnaire Each participant answered the questions of the EORTC QLQ-PRT23 questionnaire before the beginning of radiotherapy and immediately after the first, second, third and fourth weeks of treatment. The questions were always asked by an examiner blinded to the study design and type of treatment used. The EORTC QLQ-PRT23 questionnaire, originally developed in English, was translated into Portuguese following the protocol described at the EORTC Translation Procedure : The sum of points obtained by each patient through the first 21 questions of the EORTC QLQ-PRT23 was recorded. All these 21 questions received a number of points according to the intensity of each symptom or problem during the previous week, as follows: - "Not at all" = 1 point; "A little"
Sponsor: Federal University of Mato Grosso do Sul
Current Primary Outcome:
- Changes in gastrointestinal symptoms [ Time Frame: once a week during five weeks ]Patients responded to a questionnaire (EORTC QLQ-PRT23)on their gastrointestinal symptoms every week during five weeks. One week before and four weeks during their radiotherapy program we looked at the changing in gastrointestinal symptoms
- Changes in quality of life [ Time Frame: once a week during five weeks ]Patients responded to a questionnaire (EORTC QLQ-PRT23)on their quality of life every week during five weeks. One week before and four weeks during their radiotherapy program we looked at changing in quality of life
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Federal University of Mato Grosso do Sul
Dates:
Date Received: May 26, 2013
Date Started: January 2012
Date Completion:
Last Updated: July 13, 2013
Last Verified: July 2013
