Prostate Cancer Clinical Trial
Official title:
Efficacy of Symbiotic in the Reduction of Acute Radiation Proctitis Symptoms. A Randomized, Double-blind, Placebo-controlled Trial
Verified date | July 2013 |
Source | Federal University of Mato Grosso do Sul |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | November 2012 |
Est. primary completion date | November 2012 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 50 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Patients undergoing radiotherapy due to prostate cancer Exclusion Criteria: - refuse to participate, previous rectal condition or surgery, inflammatory bowel disease |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Federal University of Mato Grosso do Sul |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in gastrointestinal symptoms | 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 | No |
Primary | Changes in quality of life | 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 | No |
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