A Multicenter, Randomized, Double Blind Placebo Controlled Trial of Micronized Purified Flavonoid- Fraction (MPFF) in the Management of Radiation Proctitis
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 200
- 试验地点
- 11
- 主要终点
- Number of necessary intervention
研究概览
简要总结
national and multi-center trial for medical therapy of chronic radiation proctitis inducing anorectal bleedings
详细描述
Radiation proctitis is an inflammation of rectal mucosa, a complication following radiation therapy for cancers of the prostate, cervix, uterus, bladder and other malignancies in the pelvic area. Around 20 % of radiation patients develop radiation proctitis. There is a significant lack of trial treatments for radiation proctitis, even more, the studies often are small and single center designed or case series. In 2 recent reviews pointing out the management of radiation proctitis (2018 and 2016) a summary of current options in therapy according to current scientific knowledge is given. Unfortunately, these studies are about interventional options with the serious risk of complication. Only little data and lack of significance in smaller series on conservative strategies are given.
The goal of the trial is to implement a specific medication in the management and every grade of radiation proctitis - concomitant to eventual need of MMPF is described with potent anti-inflammatory mucosal capacity reducing bleeding, pain and urgency symptoms in patients with hemorrhoidal and/or postoperative symptoms. By using a placebo instead of comparative oral medications (with low evidence) this study might illustrate clinical significance of expected results as well as information on the natural history of radiation proctitis.
The goal of the study is to compare the number of necessary interventions required to stop bleeding in chronic radiation proctitis in patients receiving MMPF in comparison to patients in the control group receiving Placebo within 12 months of medical treatment.
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
- Double (Participant, Investigator)
盲法说明
In this double blinded study Daflon and placebo are packed in the same manner, the blind is also protected by randomization. Only the principal investigator can break the blind in case of ethical or threatening patterns by contacting the sponsor and clinical research item.
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
- •signed informed consent form
- •male and female patients
- •age ≥ 18 years
- •patients with diagnosis of radiation proctitis with macroscopic bleeding
- •end of radiotherapy ≥ 3 month = 90 days ago
排除标准
- •infectious proctitis
- •ulcerative proctitis (inflammatory bowel disease)
- •persons unable to understand the informed consent
- •persons, who are in dependent relationship with the study investigators or Sponsor
- •pregnant or lactating women
- •participation in an interventional study
研究组 & 干预措施
Investigational
Patients receive MMPF 500mg for one year
干预措施: MMPF (Micronized purified Flavonoid-Fraction) (Drug)
Placebo
Patients receive Placebo for one year
干预措施: Placebo (Other)
结局指标
主要结局
Number of necessary intervention
时间窗: Day 1- Day 360
Interventions to stop acute bleeding by chronic radiation proctitis: surgical, endoscopic or proctoscopic interventions
次要结局
- Quality of life of patients(Day 0 Day 180 Day 360)
- Blood samples(Day 0-Day 360)
- Stool(Day 0-Day 360)
- Presence of histological alterations(Day 0-Day 360)
研究者
Irmgard E Kronberger, MD
Principle Investigator
Medical University Innsbruck