Prospective, Open Clinical Trial of Thalidomide in the Treatment of Chronic Radiation Proctitis With Intractable Bleeding
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 62
- 主要终点
- Remission rate of rectal bleeding one month after thalidomide treatment
研究概览
简要总结
Chronic radiation proctitis (CRP) is the main secondary toxic injury after pelvic radiotherapy. Hematochezia is the most common symptom for more than 80% of CRP patients.
Non-surgical treatment is the first choice to the treatment of CRP to avoid the occurrence of serious complications. Conventional oral medication for the treatment of bleeding CRP is very few and has little effect. At present, no oral medication has been found to significantly alleviate and control refractory bleeding of CRP. Therefore, it is an urgent problem to screen out a drug that is more effective, safe and highly compliant for the treatment of hemorrhagic CRP.
Thalidomide has anti-inflammatory, immune regulation, anti-angiogenesis and other effects. For the patients of CRP with intractable bleeding, a prospective, open clinical trial will be carried out to observe the safety and effectiveness of thalidomide in treating hemorrhagic CRP.
详细描述
Radiotherapy is an essential therapeutic tool for pelvic malignancies such as uterine cervix, uterine corpus, prostate, testicular, urinary bladder and rectal cancers. According to reports, the estimated number of new cases of malignant pelvic tumors in China in 2015 alone exceeded 500,000. Chronic radiation proctitis (CRP) is an unavoidable and commonly observed side effect, occurs 3 months later and in 5-20% of patients after pelvic malignancy radiation. Hematochezia is the most common symptom for more than 80% of CRP patients, which is a persistent, irreversible and progressive symptom, and will probably give rise to anemia. In clinic, the treatment for intractable bleeding of CRP is very difficult.
Non-surgical treatment is the first choice to the treatment of CRP to avoid the occurrence of serious complications. Conventional oral medication for the treatment of bleeding CRP is very few and has little effect. At present, no oral medication has been found to significantly alleviate and control refractory bleeding of CRP. Therefore, it is an urgent problem to screen out a drug that is more effective, safe and highly compliant for the treatment of hemorrhagic CRP.
Thalidomide has anti-inflammatory, immune regulation, anti-angiogenesis and other effects. A large number of studies have shown that thalidomide can be used to treat Crohn's disease, ulcerative colitis, radiation cystitis, etc., and it can treat moderate to severe of IBD patients can inhibit inflammatory response, improve clinical symptoms, promote intestinal mucosal repair. Further, recent studies have proved that thalidomide can be used to treat intestinal bleeding due to vascular dysplasia. And a case report from Gut described that refractory bleeding of CRP of a 78-year-old woman were significantly alleviated after taking thalidomide.
Therefore, for the patients of CRP with intractable bleeding, a prospective, open clinical trial planed to carry out to observe the safety and effectiveness of thalidomide in treating hemorrhagic CRP.
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
- 未提供
排除标准
- •Patients with active bleeding requiring emergency treatment;
- •Patients with severe complications of CRP, such as Rectal ulcer (VRS>Grade 3) or fistula, perforation, stenosis, necrosis, perianal intractable pain and so on
- •Patients with a history of rectal resection;
- •Other bleeding diseases, such as grade III or IV hemorrhoids, coagulation dysfunction, etc.;
- •Patients with other diseases requiring long-term use of anticoagulant drugs;
- •Combined intestinal obstruction, requiring surgery;
- •The absolute value of neutrophils of patients is lower than 750/mm3;
- •Patients who are allergic to thalidomide;
- •Pregnant or lactating women;
- •Patients with severe mental illness;
- •Patients who cannot take medication or follow up as planned;
- •During the trial and within 3 months after the trial, the subjects and their partners are not willing to contraception;
- •Participants in other clinical investigators 3 months before the trial
研究组 & 干预措施
Thalidomide treatment Group
Induction period:
Thalidomide tablets: 50-100 mg/d, qn, po.
Maintenance period:
Thalidomide tablets: 50-75 mg/d qn, po.
干预措施: Thalidomide (Drug)
结局指标
主要结局
Remission rate of rectal bleeding one month after thalidomide treatment
时间窗: the first month after thalidomide treatment
Remission of rectal bleeding was defined as the score of Subjective Objective Management Analysis system (SOMA) for retcal bleeding at least 1 grade lower and the hemoglobin level at least 10g/L higher than that before treatment. The SOMA score for hematochezia was ranged from 1 to 4, with the higher the score, the more serious.
次要结局
- Remission rate of rectal bleeding one month during thalidomide treatment(the first month during thalidomide treatment)
- Remission rate of rectal bleeding two months during thalidomide treatment(the second month during thalidomide treatment)
- Remission rate of rectal bleeding three months during thalidomide treatment(the third month during thalidomide treatment)
- Remission rate of rectal bleeding four months during thalidomide treatment(the fourth month during thalidomide treatment)
- Remission rate of rectal bleeding three months after thalidomide treatment(the third month after thalidomide treatment)
- Remission rate of rectal bleeding six months after thalidomide treatment(the sixth month after thalidomide treatment)
- Endoscopic score one month during thalidomide treatment(the first month during thalidomide treatment)
- Endoscopic score four months during thalidomide treatment(the fourth month during thalidomide treatment)
- Endoscopic score one month after thalidomide treatment(the first month after thalidomide treatment)
- Endoscopic score three months after thalidomide treatment(the third month after thalidomide treatment)
- Endoscopic score six months after thalidomide treatment(the sixth month after thalidomide treatment)
- Quality of life of the patient one month during thalidomide treatment(the first month during thalidomide treatment)
- Quality of life of the patient two months during thalidomide treatment(the second month during thalidomide treatment)
- Quality of life of the patient three months during thalidomide treatment(the third month during thalidomide treatment)
- Quality of life of the patient four months during thalidomide treatment(the fourth month during thalidomide treatment)
- Quality of life of the patient one month after thalidomide treatment(the first month after thalidomide treatment)
- Quality of life of the patient three months after thalidomide treatment(the third month after thalidomide treatment)
- Quality of life of the patient six months after thalidomide treatment(the sixth month after thalidomide treatment)
- Incidence of adverse events four months during thalidomide treatment(the fourth month during thalidomide treatment)
- Incidence of adverse events six months after thalidomide treatment(the sixth month after thalidomide treatment)