Micronized purified Flavonoid- Fraction (MPFF) in the management of radiation proctitis

A multicenter, randomized, double blind placebo controlled trial of Micronized purified Flavonoid- Fraction (MPFF) in the management of radiation proctitis - MiFlaPRO

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001916-44-AT

Enrollment

200

Registered

2020-01-07

Start date

2020-01-28

Completion date

Unknown

Last updated

2022-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with radiation proctitis

Interventions

Product Name: Daflon Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Micronized purified flavonoid fraction Other descriptive name: MICRONISED PURIFIED FLAVONOIC FRACTION Concentration un

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: The goal of the study is to compare the number of necessary interventions required to stop radiation proctitis inducing rectal bleeding in patients receiving Daflon® in comparison to patients in the control group receiving Placebo within 12 months of medical treatment.;Secondary Objective: The secondary objectives of this study are to evaluate the impact of Daflon® on patients’ QoL, hemoglobin level and coagulation parameters, 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	—

Measure

Time frame

Main Objective: The goal of the study is to compare the number of necessary interventions required to stop radiation proctitis inducing rectal bleeding in patients receiving Daflon® in comparison to patients in the control group receiving Placebo within 12 months of medical treatment.;Secondary Objective: The secondary objectives of this study are to evaluate the impact of Daflon® on patients’ QoL, hemoglobin level and coagulation parameters, 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

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Secondary

Measure	Time frame
Secondary end point(s): - QoL (EORTC QLQ PRT20) - serum hemoglobin level and coagulation parameters of patients - calprotectin stool level - presence of histological alterations (distortion of crypts, - inflammation of crypts, fibrosis and ectasia of vessels, cytokines) - if available (biopsy not mandatory) - type of radiation (organ focus, Gray) - St. Mark’s Incontinence Score - Safety parameters within groups: -differences in outcomes regarding their age and sex;Timepoint(s) of evaluation of this end point: Day 30, 90, 180,360	—

Measure

Time frame

Secondary end point(s): - QoL (EORTC QLQ PRT20) - serum hemoglobin level and coagulation parameters of patients - calprotectin stool level - presence of histological alterations (distortion of crypts, - inflammation of crypts, fibrosis and ectasia of vessels, cytokines) - if available (biopsy not mandatory) - type of radiation (organ focus, Gray) - St. Mark’s Incontinence Score - Safety parameters within groups: -differences in outcomes regarding their age and sex;Timepoint(s) of evaluation of this end point: Day 30, 90, 180,360

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Countries

Austria

Contacts

Public ContactKompetenzzentrum klinische Studien

Medical University Innsbruck

miflapro@i-med.ac.at00435129003 71844

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026