Efficacy and Safety of Local Glucocorticoids for the Treatment of Acute Radiation-Induced Intestinal Injury: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Recovery and/or improvement
研究概览
简要总结
Due to the increasing number and prolonged survival of malignant tumor patients treated with radiotherapy, the complication, such as acute radiation-induced intestinal injury, has become increasingly significant. Glucocorticoids may play a therapeutic role by regulating the inflammatory response in patients with acute radiation-induced intestinal injury. However, the conclusions of related studies were controversial.
详细描述
A total of 60 patients with acute radiation-induced intestinal injury will be enrolled. They will be randomly assigned at a 1:1 ratio into glucocorticoid group and standard treatment group. The primary endpoint is the recovery and improvement of acute radiation-induced intestinal injury. The secondary study endpoints include the recurrence and aggravation of radiation-induced intestinal injury, and adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Grade II-III acute radiation-induced rectosigmoid injury
- •Signed informed consents
- •Age ≥18 years
- •Rstimated survival time >1 year
排除标准
- •Absolute contraindications to glucocorticoids
- •A history of glucocorticoids treatment within 3 months
- •Inflammatory bowel disease or infectious intestinal disease
- •Recurrence of malignant tumor
- •Colorectal cancer or metastasis
- •Severe heart or lung diseases
- •Recent history of surgery or trauma
- •Poorly controlled hyperglycemia and hypertension
- •Active tuberculosis
- •Ssevere gastrointestinal ulcers
- •Sychiatric diseases
- •Pregnant or lactating
研究组 & 干预措施
Glucocorticoids+routine treatment group
Dexamethasone retention enema
干预措施: Dexamethasone (Drug)
Glucocorticoids+routine treatment group
Dexamethasone retention enema
干预措施: Antibiotics, probiotics, vitamins, antidiarrheal drugs, enteral nutrition, and endoscopic argon plasma coagulation (Drug)
Routine treatment group
Routine treatment of acute radiation-induced intestinal injury according to the current practice guideline
干预措施: Antibiotics, probiotics, vitamins, antidiarrheal drugs, enteral nutrition, and endoscopic argon plasma coagulation (Drug)
结局指标
主要结局
Recovery and/or improvement
时间窗: 3 months
1. If patients' clinical symptoms, including abdominal pain, diarrhea, and hematochezia, and intestinal mucosal lesions under endoscopy disappear, the recovery will be defined. 2. If patients' clinical symptoms alleviate, and/or the Vienna scores evaluated by endoscopy decrease at least 1 point, the improvement will be defined. The total number and frequency of patients who have both recovery and improvement of radiation-induced intestinal injury after treatment is calculated as the treatment efficacy.
次要结局
- Recurrence and/or aggravation(1 year)
- Adverse events(1 year)
研究者
Xingshun Qi
Director of Department of Gastroenterology
General Hospital of Shenyang Military Region