Prevention of Radiotherapy Induced Enteropathy by Probiotics (PREP Trial): a Prospective, Randomized Controlled, Double Blinded, Single Center, Superiority Study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 248
- 试验地点
- 1
- 主要终点
- Number of participants with grade 2 or more acute intestinal toxicities
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •History of pelvic irradiation
- •Double primary cancer other than skin/thyroid cancer
- •Combined serious morbidity
- •Experience of other clinical trial within 1 month.
研究组 & 干预措施
Probiotics
Two weeks prior to the start of radiation therapy, the probiotics is administered three times daily until the end of radiation therapy.
干预措施: Bacillus Licheniformis (Drug)
Placebo
Two weeks prior to the start of radiation therapy, the placebo is administered three times daily until the end of radiation therapy.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with grade 2 or more acute intestinal toxicities
时间窗: Adverse effect evaluated at 3 months after radiation therapy
Evaluation using CTCAE version 4.0
次要结局
- Number of participants with grade 2 or more chronic intestinal toxicities(Adverse effect occured after 3 months since end of radiation therapy)
研究者
Young Seok Kim
Professor
Asan Medical Center