Efficacy and Safety of Thalidomide Combined With Glutamine in the Treatment of Radiation Intestinal Injury: a Single-center, Open-label, Randomized Controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 主要终点
- Treatment response rate.
研究概览
简要总结
At present, there is still a lack of standard and effective treatment strategies and procedures for radiation intestinal injury. Studies have shown that thalidomide can effectively treat refractory gastrointestinal bleeding caused by vascular malformation. Therefore, The investigators designed a single-center, open-label, randomized controlled study to evaluate the efficacy and safety of thalidomide combined with glutamine in the treatment of radiation intestinal injury.
详细描述
Screening: This phase will not last longer than one week, and the subject will be assessed for eligibility after signing the informed consent form.
Treatment: Subjects were randomly assigned to three different treatment groups for 8 weeks.
Follow-up: The subjects' defecation status was recorded every day during treatment, telephone follow-up was conducted every two weeks, and laboratory indicators (including blood routine, stool routine, etc.) were tested every four weeks. The test was terminated one week after treatment and the improvement of subjects' stool blood was assessed.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years old, gender is not limited;
- •Patients with hematochezia symptoms of chronic radiation intestinal injury: Due to the lack of diagnostic gold standard for radiation intestinal injury, a comprehensive analysis of clinical, endoscopic, imaging and histopathological findings was mainly performed to make the diagnosis of radiation intestinal injury on the basis of excluding infectious and other non-infectious intestinal injuries. Exposure to radioactive sources is a necessary factor in the diagnosis of radiation intestinal injury, and tumor activity or recurrence should be excluded.
- •The proportion of dominant defecation bleeding in total defecation times in the week before treatment is not less than 20%;
- •ECOG score: 0-2.
排除标准
- •Patients with hemodynamic instability;
- •Patients with obvious liver and kidney function injury: bilirubin, aminotransferase (ALT, AST) exceeded the upper limit of normal by 2 times; eGFR<60ml/min or dialysis patients;
- •Patients allergic to thalidomide or glutamine;
- •Patients whose primary disease was gastrointestinal malignancy;
- •Patients currently suffering from serious or uncontrolled underlying diseases of the blood, digestive tract, metabolism, endocrine, lung, heart, nervous system, mental system, etc.;
- •Female patients during pregnancy and breastfeeding (including patients with reproductive needs);
- •Patients infected with HIV;
- •Patients who cannot cooperate with regular follow-up and review of laboratory indicators;
- •any other circumstances which, in the opinion of the investigator, would render the subject unfit for study inclusion.
研究组 & 干预措施
The thalidomide group
Patients in the thalidomide group will receive oral thalidomide at a dosage of 100 mg one time daily for 8 weeks.
干预措施: Thalidomide (Drug)
The glutamine group
Patients in the glutamine group were given two enteric-soluble capsules of compound glutamine three times a day for 8 weeks.
干预措施: Glutamine (Drug)
The thalidomide combined with glutamine group
Patients in the thalidomide combined with glutamine group will receive oral thalidomide at a dosage of 100 mg one time daily and two enteric-soluble capsules of compound glutamine three times a day for 8 weeks.
干预措施: Thalidomide+Glutamine (Drug)
结局指标
主要结局
Treatment response rate.
时间窗: From enrollment to the end of treatment at 8 weeks.
The proportion of overt defecation bleeding in total defecation within 1 week after treatment was reduced by ≥50% compared with 1 week before treatment.
次要结局
- Hemoglobin level(From enrollment to the end of treatment at 8 weeks.)
- Number of hospitalizations due to bleeding(From enrollment to the end of treatment at 8 weeks.)
- No further bleeding occurred within 1 week after treatment(From enrollment to the end of treatment at 8 weeks.)
- Number of blood transfusions during the treatment period(From enrollment to the end of treatment at 8 weeks.)
- Red blood cell input(From enrollment to the end of treatment at 8 weeks.)
- Number of days in hospital due to bleeding(From enrollment to the end of treatment at 8 weeks.)
- Require surgery(From enrollment to the end of treatment at 8 weeks.)
研究者
Yongquan Shi
Professor
Xijing Hospital of Digestive Diseases