- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01901042
Efficacy of Symbiotic in the Reduction of Acute Radiation Proctitis Symptoms
Efficacy of Symbiotic in the Reduction of Acute Radiation Proctitis Symptoms. A Randomized, Double-blind, Placebo-controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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).
|
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:
|
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
|
Control patients will receive sachets containing maltodextrin
Other Names:
|
What is the study measuring?
Primary Outcome Measures
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
Investigators
- Principal Investigator: Jose E Aguilar-Nascimento, MD, PhD, Federal University of Mato Grosso
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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.
Clinical Trials on Prostate Cancer
-
Roswell Park Cancer InstituteRecruitingObesity | Overweight | Cancer Survivor | Prostate Adenocarcinoma | Stage I Prostate Cancer | Stage II Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate Cancer | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer | Stage A Prostate Cancer | Stage... and other conditionsUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Regeneron Pharmaceuticals; Prostate Cancer FoundationWithdrawnStage III Prostate Cancer | Stage IV Prostate Cancer | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer | Stage IIIA Prostate Cancer | Stage IIIB Prostate Cancer | Stage IIIC Prostate Cancer
-
Jonsson Comprehensive Cancer CenterProgenics Pharmaceuticals, Inc.TerminatedRandomized Trial of PSMA PET Scan Before Definitive Radiation Therapy for Prostate Cancer (PSMA-dRT)Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IIA Prostate Cancer AJCC v8 | Stage IIB Prostate Cancer AJCC v8 | Stage I Prostate...United States
-
University of Southern CaliforniaNational Cancer Institute (NCI); SanofiTerminatedDiarrhea | Recurrent Prostate Cancer | Hormone-resistant Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Ryan Kohlbrenner, MDRadiological Society of North AmericaCompletedProstate Adenocarcinoma | Stage IV Prostate Cancer AJCC v8 | Prostate Carcinoma | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IVA Prostate Cancer AJCC v8 | Stage...United States
-
Mayo ClinicNational Cancer Institute (NCI)WithdrawnStage I Prostate Cancer AJCC v8 | Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IIA Prostate Cancer AJCC v8 | Stage IIB Prostate...United States
-
Barbara Ann Karmanos Cancer InstituteGenentech, Inc.CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Ohio State University Comprehensive Cancer CenterRiverside Methodist HospitalCompletedStage I Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
University of California, IrvineCompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
Clinical Trials on Symbiotic
-
Mashhad University of Medical SciencesUnknown
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...University of Bari Aldo MoroCompletedHealthy | Chronic Kidney DiseasesItaly
-
Conselho Nacional de Desenvolvimento Científico...CompletedSigns and Symptoms, Digestive | Dyslipidemia | HIV | Dietary ModificationBrazil
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...University of Bari Aldo MoroCompleted
-
Federal University of Minas GeraisCompletedHead and Neck Cancer | Nutrition Therapy | SynbioticsBrazil
-
Peking Union Medical College HospitalNot yet recruiting
-
Zeynep Kamil Maternity and Pediatric Research and...Completed
-
Hospital de Clinicas de Porto AlegreUnknownColorectal Cancer | Surgical Site InfectionBrazil
-
National University Hospital, SingaporeNational University of SingaporeNot yet recruitingCardiovascular Diseases | Metabolic Syndrome | Non-Alcoholic Fatty Liver Disease
-
Fondazione Don Carlo Gnocchi OnlusUnknownMalnutrition | Pressure UlcerItaly