Efficacy and Safety of Adjunctive Use of Rifaximin In Preventing Radiotherapy-induced Diarrhea in Cancer Patients
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The difference in the incidence and severity of radiotherapy induced diarrhea grade 2 or more according to Common Terminology Criteria for Adverse Events (CTCAE)in cancer patients undergo pelvic irradiation.
研究概览
简要总结
Preclinical data indicate that rifaximin could be repurposed as a novel strategy for preventing and reducing the severity of gastrointestinal damage, particularly diarrhea, that results from pelvic irradiation. So, The aim of the work is to investigate the impact of Rifaximin on the incidence and severity of radiotherapy-induced diarrhea in cancer patients undergoing pelvic irradiation with or without chemotherapy.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals who are 18 years of age or older and have been diagnosed with non metastatic pelvic cancers.
- •Patients who are undergoing curative intent radiotherapy with or without chemotherapy treatment.
排除标准
- •Patients who have a record of intestinal resection in their medical history.
- •Patients with a medical background of irritable bowel syndrome.
- •Patients with a history of inflammatory bowel disease.
- •Patients who regularly take anti-diarrheal medications before commencing radiotherapy.
- •Patients experiencing diarrhea at the outset of the study.
- •Patients with compromised immune systems, such as those who are HIV positive or using immunosuppressive medications.
- •Pregnant or lactating woman.
- •Patients allergic to rifamycin.
研究组 & 干预措施
Control Arm
干预措施: Standard Care Chemoradiation (Drug)
Patients will receive Rifaximin 550 MG in addition to Pelvic Radiotherapy with/not chemotherapy
干预措施: Rifaximin 550 MG (Drug)
结局指标
主要结局
The difference in the incidence and severity of radiotherapy induced diarrhea grade 2 or more according to Common Terminology Criteria for Adverse Events (CTCAE)in cancer patients undergo pelvic irradiation.
时间窗: 12 months
次要结局
未报告次要终点
研究者
Noha Mansour
Associate professsor
Mansoura University