Efficacy of Symbiotic in the Reduction of Acute Radiation Proctitis Symptoms

July 13, 2013 updated by: Jose Eduardo de Aguilar-Nascimento, Federal University of Mato Grosso

Efficacy of Symbiotic in the Reduction of Acute Radiation Proctitis Symptoms. A Randomized, Double-blind, Placebo-controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Patients undergoing radiotherapy due to prostate cancer

Exclusion Criteria:

  • refuse to participate, previous rectal condition or surgery, inflammatory bowel disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Symbiotic
Patients in this group received 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).
Dietary supplement: Symbiotic
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).
Other Names:
  • FiberMais Flora (Nestlé, Brazil)
PLACEBO_COMPARATOR: Maltodextrin
patients in this group received sachets five grams of maltodextrin per sachet with identical casing and identical aspect to the product of the other arm group, and were instructed to proceed in the same way as those of the symbiotic group
Dietary supplement: Maltodextrin
Control patients will receive sachets containing maltodextrin
Other Names:
  • Placebo supplement

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
once a week during five weeks
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
once a week during five weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Federal University of Mato Grosso

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jose E Aguilar-Nascimento, MD, PhD, Federal University of Mato Grosso

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 26, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 17, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 17, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • marianan

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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