Efficacy of Symbiotic in the Reduction of Acute Radiation Proctitis Symptoms

NCT01901042 | Completed Phase 2 DMC

• 1 other identifier: marianan
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Radiation Proctitis; Prostate Cancer

Keywords

Quality of life; Symbiotic; Proctitis/Radiotherapy

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Symbiotic

EXPERIMENTAL

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

Maltodextrin

PLACEBO COMPARATOR

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

Interventions

Symbiotic DIETARY_SUPPLEMENT

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).

Also known as: FiberMais Flora (Nestlé, Brazil)

Symbiotic

Maltodextrin DIETARY_SUPPLEMENT

Control patients will receive sachets containing maltodextrin

Also known as: Placebo supplement

Maltodextrin

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing radiotherapy due to prostate cancer

You may not qualify if:

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

Sponsors & Collaborators

• Federal University of Mato Grosso: lead

MeSH Terms

Conditions

Prostatic Neoplasms; Proctitis

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Rectal Diseases; Intestinal Diseases

Study Officials

• JOSE E AGUILAR-NASCIMENTO, MD, PhD

  Federal University of Mato Grosso

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: May 26, 2013
• First Posted: July 17, 2013
• Study Start: January 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: July 17, 2013

Record last verified: 2013-07