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

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.

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.

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

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

Interventions to stop acute bleeding by chronic radiation proctitis: surgical, endoscopic or proctoscopic interventions

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.

Differences in histological alterations (distortion of crypts, Inflammation of crypts, fibrosis and ectasia of vessels, cytokines)

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