Prevention of Radiotherapy Induced Enteropathy by Probiotics (PREP)

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

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.

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.