Micronized purified Flavonoid-Fraction (MPFF) in the managementof radiation proctitis
Phase 1
- Conditions
- Patients with radiation proctitisTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2019-001916-44-AT
- Lead Sponsor
- Medical University Innsbruck, Department of Visceral, Transplant und Thoracic Surgery
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
signed informed consent form
male and female patients
age = 18 years
patients with diagnosis of radiation proctitis with macroscopic bleeding
end of radiotherapiy >= 3 month = 90 days
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150
Exclusion Criteria
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The goal of the study is to compare the number of necessary interventions<br>required to stop radiation proctitis inducing rectal bleeding in patients receiving Daflon® in comparison to patients in the<br>control group receiving Placebo within 12 months of medical treatment.;Secondary Objective: The secondary objectives of this study are to evaluate the impact of<br>Daflon® on patients’ QoL, hemoglobin level and coagulation parameters,<br>calprotectin, cytokines and histological alterations. Furthermore, we want to assess if different types of radiation (organ focus, Gray) or grades of incontinence have an impact on the primary endpoint.;Primary end point(s): number of necessary interventions within 1 year;Timepoint(s) of evaluation of this end point: Day 360
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - QoL (EORTC QLQ PRT20)<br>- serum hemoglobin level and coagulation parameters of patients<br>- calprotectin stool level<br>- presence of histological alterations (distortion of crypts,<br>- inflammation of crypts, fibrosis and ectasia of vessels, cytokines)<br>- if available (biopsy not mandatory)<br>- type of radiation (organ focus, Gray)<br>- St. Mark’s Incontinence Score<br>- Safety parameters<br>within groups:<br>-differences in outcomes regarding their age and sex;Timepoint(s) of evaluation of this end point: Day 30, 90, 180,360