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

Sponsor

Medical University Innsbruck (Other)

Overall Status

Recruiting

CT.gov ID

NCT04335617

Collaborator

Servier Affaires Médicales (Industry)

200

Enrollment

Locations

Arms

Anticipated Duration (Months)

18.2

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Proctitis Radiation	Drug: MMPF (Micronized purified Flavonoid-Fraction) Other: Placebo	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This is a multicenter, randomized, double-blind, placebo-controlled Phase III study.This is a multicenter, randomized, double-blind, placebo-controlled Phase III study.

Masking:

Double (Participant, Investigator)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 26, 2020

Anticipated Primary Completion Date :

Feb 26, 2023

Anticipated Study Completion Date :

Aug 26, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Number of necessary intervention [Day 1- Day 360]
Interventions to stop acute bleeding by chronic radiation proctitis: surgical, endoscopic or proctoscopic interventions

Secondary Outcome Measures

Quality of life of patients [Day 0 Day 180 Day 360]
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.
Blood samples [Day 0-Day 360]
Differences in serum hemoglobin, thrombocytes, coagulation parameters (quick/pt=prothrombin time)
Stool [Day 0-Day 360]
Differences in calprotectin stool level
Presence of histological alterations [Day 0-Day 360]
Differences in histological alterations (distortion of crypts, Inflammation of crypts, fibrosis and ectasia of vessels, cytokines)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medizinische Universität Innsbruck	Innsbruck	Tyrol	Austria	6020
2	Krankenhaus der Stadt Dornbirn	Dornbirn		Austria	6850
3	Barmherzige Brüder Krankenhaus Graz	Graz		Austria	8020
4	Medizinische Universität Graz	Graz		Austria	8036
5	Universitätsklinikum Krems	Krems		Austria	3500
6	Ordensklinikum Linz GmbH Elisabethinen	Linz		Austria	4020
7	Kepleruniversität Linz	Linz		Austria	4040
8	Universitätsklinikum Tulln	Tulln		Austria	3430
9	Salzkammergut Klinikum Vöcklabruck	Vöcklabruck		Austria	4840
10	Medizinische Universität Wien	Wien		Austria	1090
11	Krankenhaus Nord, Klinik Floridsdorf	Wien		Austria	1210

Sponsors and Collaborators

Medical University Innsbruck
Servier Affaires Médicales

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Irmgard E Kronberger, MD, Principle Investigator, Medical University Innsbruck

ClinicalTrials.gov Identifier:

NCT04335617

Other Study ID Numbers:

MiFlaPRO_2019

First Posted:

Apr 6, 2020

Last Update Posted:

Nov 3, 2020

Last Verified:

Oct 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Proctitis

Study Results

No Results Posted as of Nov 3, 2020