Micronized Purified Flavonoid- Fraction (MPFF) in the Management of Radiation Proctitis (MiFlaPRO)

A Multicenter, Randomized, Double Blind Placebo Controlled Trial of Micronized Purified Flavonoid- Fraction (MPFF) in the Management of Radiation Proctitis

national and multi-center trial for medical therapy of chronic radiation proctitis inducing anorectal bleedings

Study Overview

• Status: Recruiting
• Conditions: Proctitis Radiation
• Intervention / Treatment: Drug: MMPF (Micronized purified Flavonoid-Fraction); Other: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Irmgard Kronberger, MD; Phone Number: +43 512 504; Email: irmgard.kronberger@i-med.ac.at
• Study Contact Backup: Name: Marijana Ninkovic, MD; Phone Number: +43 512 504; Email: marijana.ninkovic@i-med.ac.at

Study Locations

• Austria
  • Dornbirn, Austria, 6850
    • Not yet recruiting
    • Krankenhaus der Stadt Dornbirn
    • Contact: Clemens Obwegeser, Dr.
  • Graz, Austria, 8036
    • Recruiting
    • Medizinische Universität Graz
    • Contact: Martina Lemmerer, Dr.
  • Graz, Austria, 8020
    • Recruiting
    • Barmherzige Brüder Krankenhaus Graz
    • Contact: Martin Mitteregger, Dr.
  • Krems, Austria, 3500
    • Recruiting
    • Universitätsklinikum Krems
    • Contact: Stefan Sattler, Dr.
  • Linz, Austria, 4020
    • Recruiting
    • Ordensklinikum Linz GmbH Elisabethinen
    • Contact: Ulrike Enkner, Dr.
  • Linz, Austria, 4040
    • Recruiting
    • Kepleruniversität Linz
    • Contact: Günther Klimbacher, Dr.
  • Tulln, Austria, 3430
    • Recruiting
    • Universitätsklinikum Tulln
    • Contact: Alf-Dorian Binder, Dr.
  • Vöcklabruck, Austria, 4840
    • Recruiting
    • Salzkammergut Klinikum Vöcklabruck
    • Contact: Raimund Strouhal, Dr.
  • Wien, Austria, 1090
    • Recruiting
    • Medizinische Universitat Wien
    • Contact: Stefan Riss, Assoc.-Prof.
  • Wien, Austria, 1210
    • Recruiting
    • Krankenhaus Nord, Klinik Floridsdorf
    • Contact: Zacaria Sow, Dr.
  • Tyrol
    • Innsbruck, Tyrol, Austria, 6020
      • Recruiting
      • Medizinische Universität Innsbruck
      • Contact: Irmgard E Kronberger, MD; Email: irmgard.kronberger@i-med.ac.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Investigational; Patients receive MMPF 500mg for one year	Drug: MMPF (Micronized purified Flavonoid-Fraction); 500mg film-coated tablet, oral route, tablets should be taken at meal times. 4-day course of 6 tablets daily, followed by 4 tablets over the next 3 days followed by 2 tablets daily, one at midday and one in the evening
Placebo Comparator: Placebo; Patients receive Placebo for one year	Other: Placebo; 4-day course of 6 tablets daily, followed by 4 tablets over the next 3 days followed by 2 tablets daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of necessary intervention	Interventions to stop acute bleeding by chronic radiation proctitis: surgical, endoscopic or proctoscopic interventions	Day 1- Day 360

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life of patients	Differences in quality of life of patients will be measured with evaluation of two questionnaires (EORTC QLQ C30 & PRT20). Higher scores mean a better quality of life.	Day 0 Day 180 Day 360
Blood samples	Differences in serum hemoglobin, thrombocytes, coagulation parameters (quick/pt=prothrombin time)	Day 0-Day 360
Stool	Differences in calprotectin stool level	Day 0-Day 360
Presence of histological alterations	Differences in histological alterations (distortion of crypts, Inflammation of crypts, fibrosis and ectasia of vessels, cytokines)	Day 0-Day 360

Collaborators and Investigators

• Sponsor: Medical University Innsbruck
• Collaborators: Servier Affaires Médicales

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2020
• Primary Completion (Anticipated): February 26, 2023
• Study Completion (Anticipated): August 26, 2023

Study Registration Dates

• First Submitted: December 13, 2019
• First Submitted That Met QC Criteria: April 2, 2020
• First Posted (Actual): April 6, 2020

Study Record Updates

• Last Update Posted (Actual): November 3, 2020
• Last Update Submitted That Met QC Criteria: October 30, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Rectal Diseases; Proctitis
• Other Study ID Numbers: MiFlaPRO_2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No