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

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ClinicalTrials.gov Identifier: NCT04335617
Recruitment Status : Recruiting
First Posted : April 6, 2020
Last Update Posted : November 3, 2020
Sponsor:
Collaborator:
Servier Affaires Médicales
Information provided by (Responsible Party):
Irmgard E Kronberger, MD, Medical University Innsbruck

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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 : February 26, 2020
Estimated Primary Completion Date : February 26, 2023
Estimated Study Completion Date : August 26, 2023
Arms and Interventions
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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
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Primary Outcome Measures :
  1. Number of necessary intervention [ Time Frame: Day 1- Day 360 ]
    Interventions to stop acute bleeding by chronic radiation proctitis: surgical, endoscopic or proctoscopic interventions


Secondary Outcome Measures :
  1. Quality of life of patients [ Time Frame: 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.

  2. Blood samples [ Time Frame: Day 0-Day 360 ]
    Differences in serum hemoglobin, thrombocytes, coagulation parameters (quick/pt=prothrombin time)

  3. Stool [ Time Frame: Day 0-Day 360 ]
    Differences in calprotectin stool level

  4. Presence of histological alterations [ Time Frame: Day 0-Day 360 ]
    Differences in histological alterations (distortion of crypts, Inflammation of crypts, fibrosis and ectasia of vessels, cytokines)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04335617


Contacts
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Contact: Irmgard Kronberger, MD +43 512 504 ext 0 irmgard.kronberger@i-med.ac.at
Contact: Marijana Ninkovic, MD +43 512 504 ext 0 marijana.ninkovic@i-med.ac.at

Locations
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Austria
Medizinische Universität Innsbruck Recruiting
Innsbruck, Tyrol, Austria, 6020
Contact: Irmgard E Kronberger, MD       irmgard.kronberger@i-med.ac.at   
Krankenhaus der Stadt Dornbirn Not yet recruiting
Dornbirn, Austria, 6850
Contact: Clemens Obwegeser, Dr.         
Barmherzige Brüder Krankenhaus Graz Recruiting
Graz, Austria, 8020
Contact: Martin Mitteregger, Dr.         
Medizinische Universität Graz Recruiting
Graz, Austria, 8036
Contact: Martina Lemmerer, Dr.         
Universitätsklinikum Krems Recruiting
Krems, Austria, 3500
Contact: Stefan Sattler, Dr.         
Ordensklinikum Linz GmbH Elisabethinen Recruiting
Linz, Austria, 4020
Contact: Ulrike Enkner, Dr.         
Kepleruniversität Linz Recruiting
Linz, Austria, 4040
Contact: Günther Klimbacher, Dr.         
Universitätsklinikum Tulln Recruiting
Tulln, Austria, 3430
Contact: Alf-Dorian Binder, Dr.         
Salzkammergut Klinikum Vöcklabruck Recruiting
Vöcklabruck, Austria, 4840
Contact: Raimund Strouhal, Dr.         
Medizinische Universität Wien Recruiting
Wien, Austria, 1090
Contact: Stefan Riss, Assoc.-Prof.         
Krankenhaus Nord, Klinik Floridsdorf Recruiting
Wien, Austria, 1210
Contact: Zacaria Sow, Dr.         
Sponsors and Collaborators
Medical University Innsbruck
Servier Affaires Médicales
More Information
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Responsible Party: Irmgard E Kronberger, MD, Principle Investigator, Medical University Innsbruck
ClinicalTrials.gov Identifier: NCT04335617    
Other Study ID Numbers: MiFlaPRO_2019
First Posted: April 6, 2020    Key Record Dates
Last Update Posted: November 3, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Proctitis
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Rectal Diseases
Intestinal Diseases