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

Medical University Innsbruck

Status and phase: Unknown; Phase 3

Conditions: Proctitis Radiation

Treatments: Drug: MMPF (Micronized purified Flavonoid-Fraction); Other: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04335617

MiFlaPRO_2019

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups, including a placebo group

Investigational

Experimental group

Description:

Patients receive MMPF 500mg for one year

Treatment:

Drug: MMPF (Micronized purified Flavonoid-Fraction)

Placebo

Placebo Comparator group

Description:

Patients receive Placebo for one year

Treatment:

Other: Placebo