Prevention of Radiotherapy Induced Enteropathy by Probiotics (PREP)

Study Overview
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Brief Summary
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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.

Official Title
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Prevention of Radiotherapy Induced Enteropathy by Probiotics (PREP Trial): a Prospective, Randomized Controlled, Double Blinded, Single Center, Superiority Study

Conditions
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Radiotherapy, Toxicity, Diarrhea, Probiotics

Intervention / Treatment
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* Drug: Bacillus Licheniformis
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotics<br>Two weeks prior to the start of radiation therapy, the probiotics is administered three times daily until the end of radiation therapy. | Drug: Bacillus Licheniformis<br>* Two weeks prior to the start of radiation therapy, the probiotics is administered three times daily until the end of radiation therapy.<br>* Other names: Biscanen cap.;|
| Placebo Comparator: Placebo<br>Two weeks prior to the start of radiation therapy, the placebo is administered three times daily until the end of radiation therapy. | Drug: Placebo<br>* Two weeks prior to the start of radiation therapy, the placebo is administered three times daily until the end of radiation therapy.<br>* Other names: Placebo oral tablet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with grade 2 or more acute intestinal toxicities | Evaluation using CTCAE version 4.0 | Adverse effect evaluated at 3 months after radiation therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with grade 2 or more chronic intestinal toxicities | Evaluation using CTCAE version 4.0 | Adverse effect occured after 3 months since end of radiation therapy |