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

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    Medical University Innsbruck
Updated on 3 March 2022


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


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.

Condition Proctitis Radiation
Treatment Placebo, Daflon, Daflon, MMPF (Micronized purified Flavonoid-Fraction)
Clinical Study IdentifierNCT04335617
SponsorMedical University Innsbruck
Last Modified on3 March 2022


Yes No Not Sure

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
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