NCT04335617

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Medical University Innsbruck · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Proctitis Radiation

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-02-26
• Primary completion: 2023-02-26
• Completion: 2023-08-26
• First posted: 2020-04-06
• Last updated: 2020-11-03

Locations

11 sites across 1 country: Austria