A Prospective, Single-Arm, Single-Center Study of Dietary Supplements in the Treatment of Radiation-Induced Rectal Injury
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Number of participants with alleviated rectal bleeding (degraded by 1 or more)
研究概览
简要总结
This clinical study is a prospective, single-arm, single-center trial aimed at assessing the safety and efficacy of tributyrin (TB) as dietary supplements in the treatment of chronic radiation-induced rectal injury (RRI). We hypothesize that these supplements will help improve rectal bleeding symptoms and elevate the quality of life for patients. The study will test whether the supplements can lower the LENT-SOMA scales of rectal bleeding and enhance overall patient health. Efficacy will be evaluated through blood tests and other non-invasive methods, ensuring patient safety and comfort throughout the 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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years
- •At least 3 months since the completion of pelvic radiotherapy
- •No evidence of tumor recurrence or metastasis
- •Rectal bleeding with grade 1-2 by LENT-SOMA scales
排除标准
- •Acute or chronic infectious diseases
- •Serious systemic diseases
- •Known allergies to any components of the study medication
- •Colonoscopy indicating rectal ulceration (>1cm2), fistula, stricture, or necrosis
- •Late complications related to pelvic radiation injury
- •Other hemorrhagic or coagulation disorders
- •Previous rectal resection
- •Bowel obstruction or perforation that require surgery
- •Cognitive or psychological disorder
研究组 & 干预措施
Dietary supplements
Participants receive dietary supplements combined with supportive care.
干预措施: Butyrate (Dietary Supplement)
结局指标
主要结局
Number of participants with alleviated rectal bleeding (degraded by 1 or more)
时间窗: At the time of 12 weeks since the start of treatment
The symptom of rectal bleeding will be assessed by LENT-SOMA scales
次要结局
- Number of participants with mild rectal bleeding (grade 0-1)(At the time of 24 weeks since the start of treatment)