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

Proctitis Radiation Clinical Trial

— MiFlaPRO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04335617
• Other study ID #: MiFlaPRO_2019
• Status: Recruiting
• Phase: Phase 3
• Start date: February 26, 2020
• Est. completion date: August 26, 2023

Study information

• Verified date: October 2020
• Source: Medical University Innsbruck
• Contact: Irmgard Kronberger, MD
• Phone: +43 512 504
• Email: irmgard.kronberger[@]i-med.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 26, 2023
• Est. primary completion date: February 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Proctitis
• Proctitis Radiation

Intervention

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

Other:
• Placebo
4-day course of 6 tablets daily, followed by 4 tablets over the next 3 days followed by 2 tablets daily

Locations

Country	Name	City	State
Austria	Krankenhaus der Stadt Dornbirn	Dornbirn
Austria	Barmherzige Brüder Krankenhaus Graz	Graz
Austria	Medizinische Universität Graz	Graz
Austria	Medizinische Universität Innsbruck	Innsbruck	Tyrol
Austria	Universitätsklinikum Krems	Krems
Austria	Kepleruniversität Linz	Linz
Austria	Ordensklinikum Linz GmbH Elisabethinen	Linz
Austria	Universitätsklinikum Tulln	Tulln
Austria	Salzkammergut Klinikum Vöcklabruck	Vöcklabruck
Austria	Krankenhaus Nord, Klinik Floridsdorf	Wien
Austria	Medizinische Universität Wien	Wien

Sponsors (2)

Lead Sponsor	Collaborator
Medical University Innsbruck	Servier Affaires Médicales

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of necessary intervention	Interventions to stop acute bleeding by chronic radiation proctitis: surgical, endoscopic or proctoscopic interventions	Day 1- Day 360
Secondary	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
Secondary	Blood samples	Differences in serum hemoglobin, thrombocytes, coagulation parameters (quick/pt=prothrombin time)	Day 0-Day 360
Secondary	Stool	Differences in calprotectin stool level	Day 0-Day 360
Secondary	Presence of histological alterations	Differences in histological alterations (distortion of crypts, Inflammation of crypts, fibrosis and ectasia of vessels, cytokines)	Day 0-Day 360