Efficacy of Symbiotic in the Reduction of Acute Radiation Proctitis Symptoms
Condition: Radiation Proctitis; Prostate Cancer
MeSH terms: Proctitis
Study type: Interventional
Phase: Phase 2/Phase 3

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 description: 
      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" = 2 points; "Quite a bit" = 3 points; and "Very
      much" = 4 points.

      Radiotherapy protocol A total dose of 66-76 Gy during 6-8 weeks was programmed for each
      individual. Patients were followed-up until the fourth week of radiotherapy and the
      cumulative dose of radiation was compared weekly between the two groups. Each patient was
      scheduled to receive a dose of two grays (Gy) per day, from Monday to Friday with weekend
      interval, totaling 10 Gy per week and 40 Gy after the 4th week of treatment. The irradiated
      rectal volume after an accumulated dose of 40 Gy was compared between the two groups using
      dose-volume histograms and presented in percentages of the rectal volume which received 10 Gy
      (V10), 20 Gy (V20), 30 Gy (V30), and 40 Gy (V40).

      Outcome variables The endpoints of the study were the intensity of the gastrointestinal
      symptoms and quality of life. All patients were scored with the sum of questions from 1 to 21
      to represent both gastrointestinal symptoms and quality of life; and the sum of the scores
      obtained with questions numbered from 1 to 15, which refer only to gastrointestinal symptoms.
      Presence of blood in stools and tenesmus intensity were also assessed according to the score
      described above and used in the questionnaire. It was also recorded the maximum number of
      evacuations that each patient had over a period of 24 hours each week.

      Statistical analysis For the calculation of the sample, it was estimated that the symbiotic
      group would present a median of four points lower than the score of the placebo group over
      four weeks. A total of twenty patients (10 in each group) was calculated considering an error
      alpha of 1% and a beta error of 90%. The Statistical Package for Social Sciences (SPSS) for
      Windows 9.0 was used for statistical analysis. A level of 5% (p <0,05) was established for
      significance. Fischer's test or chi-square test was used for categorical variables. For
      continuous data, we used the Mann-Whitney or Student's t according to the homogeneity (Levene
      test) and normality (Kolgomorov-Smirnov test) data. Repeated measures ANOVA was used to
      analyze the responses obtained by the EORTC QLQ-PRT23 questionnaire.
    

Intervention name(s): Symbiotic; Maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Sachets with 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).; Control patients will receive sachets containing maltodextrin
Other intervention name(s): FiberMais Flora (Nestlé, Brazil); Placebo supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Quality of life; Symbiotic; Proctitis/Radiotherapy