Prevention of Radiotherapy Induced Enteropathy by Probiotics (PREP)

Asan Medical Center248 enrolled

Overview

In recent studies, a radiation-induced enteropathy is being reported over 50%. In clinics, probiotics are actively prescribed as a treatment for radiation-induced enteropathy. If probiotics can be used during radiation therapy to prevent or reduce radiation-induced enteropathy, the investigators can 1) reduce the inconvenience which is caused from intestinal toxicity, 2) reduce the unnecessary interruption of radiation therapy, and 3) expect to improve the quality of life.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

248

Conditions

Radiotherapy Toxicity Diarrhea Probiotics

Interventions

Bacillus LicheniformisDRUG

Two weeks prior to the start of radiation therapy, the probiotics is administered three times daily until the end of radiation therapy.

PlaceboDRUG

Two weeks prior to the start of radiation therapy, the placebo is administered three times daily until the end of radiation therapy.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologically proven uterine cancer, ovarian cancer, vaginal cancer, vulvar cancer, ureter cancer, kidney cancer, urethral cancer, and prostate cancer * Over 20 years of age * Eastern Cooperative Oncology Group (ECOG) score 0-2 * Appropriate values of blood test within 6 months after enrollment Absolute neutrophil count (ANC) ≥ 1500 cells/mm3, platelets≥50000cells/mm3 * Appropriate values of kidney function within 6 months after enrollment Creatinin \< 2.0 ng/dL * Appropriate values of liver function within 6 months after enrollment Total bilirubin \< 1.5 times upper limit normal range, alanine aminotransferase or aspartate aminotransferase \< 2.5 times upper limit normal range. * Willing to provide informed written consent Exclusion Criteria: * History of pelvic irradiation * Double primary cancer other than skin/thyroid cancer * Combined serious morbidity * Experience of other clinical trial within 1 month.

Locations (1)

Asan Medical Center

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

Number of participants with grade 2 or more acute intestinal toxicities

Evaluation using CTCAE version 4.0

Time frame: Adverse effect evaluated at 3 months after radiation therapy

Secondary Outcomes

Number of participants with grade 2 or more chronic intestinal toxicities

Evaluation using CTCAE version 4.0

Time frame: Adverse effect occured after 3 months since end of radiation therapy

Central Contacts

Young Seok Kim, M.D., PhD.

CONTACT

82 2 3010 5614 ysk@amc.seoul.kr

Data from ClinicalTrials.gov

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