Clinical Observation of Trolamine Retention Enema in Preventing Acute Radiation-induced Rectal Injury: a Real-world Multicenter Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Occurrence time of acute and chronic radiation rectal injury
研究概览
简要总结
The main objective of this study was to evaluate the efficacy and safety of drug retention enema for the prevention of acute radiation rectal injury in the real world.
详细描述
The study was a prospective, multicenter, real-world study with eligible patient data as of May 1, 2024. The prospective study was a continuous, multicenter study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •There are clear indications for radiotherapy (pelvic radiotherapy or rectal radiotherapy) according to relevant guidelines;
- •ECOG score 0-1;
- •normal mind, clear consciousness;
- •High compliance;
- •Able to cooperate with the interviewer
排除标准
- •Poor compliance, unwilling to participate or unable to cooperate with the interviewer;
- •Patients with other intestinal diseases (such as Crohn's disease, rectal ulcer, anal fissure, anal fistula, hemorrhoids, etc.) and perianal diseases;
- •serious heart, brain, liver, kidney disease;
- •Long-term immune dysfunction;
- •Pregnant or lactating women;
- •Patients who terminate treatment for various reasons.
研究组 & 干预措施
Triethanolamine cream group
Triethanolamine cream retention enema was given once every night before going to bed during radiotherapy until the end of radiotherapy. Triethanolamine cream retention enema was given once before going to bed the day after radiotherapy for 3 months
干预措施: Triethanolamine cream (Drug)
结局指标
主要结局
Occurrence time of acute and chronic radiation rectal injury
时间窗: Up to approximately 4 months
RTOG/EORTC criteria were used to evaluate the severity of acute and chronic radiation rectal injury. The time (days) of acute radiation rectal injury were evaluated and recorded
Evaluation of acute and chronic radiation rectal injury
时间窗: Up to approximately 4 months
RTOG/EORTC criteria were used to evaluate the severity of acute and chronic radiation rectal injury. The grading of acute radiation rectal injury were evaluated and recorded
次要结局
- Clinical symptom assessment(Up to approximately 4 months)
- Quality of life assessment assessed by IBDQ(Up to approximately 4 months)