Clinical trial NCT04335617: Micronized Purified Flavonoid- Fraction (MPFF) in the Management of Radiation Proctitis
Official title: A Multicenter, Randomized, Double Blind Placebo Controlled Trial of Micronized Purified Flavonoid- Fraction (MPFF) in the Management of Radiation Proctitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Proctitis Radiation
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
Collaborators: name: Servier Affaires Médicales
First posted: 2020-04-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a multicenter, randomized, double-blind, placebo-controlled Phase III study.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of necessary intervention
timeFrame: Day 1- Day 360
Secondary outcomes:
measure: Quality of life of patients
timeFrame: Day 0 Day 180 Day 360
measure: Blood samples
timeFrame: Day 0-Day 360
measure: Stool
timeFrame: Day 0-Day 360
measure: Presence of histological alterations
timeFrame: Day 0-Day 360
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medizinische Universität Innsbruck
state: Tyrol
city: Dornbirn
country: Austria
facility: Krankenhaus der Stadt Dornbirn
city: Graz
country: Austria
facility: Barmherzige Brüder Krankenhaus Graz
city: Graz
country: Austria
facility: Medizinische Universität Graz
city: Krems
country: Austria
facility: Universitätsklinikum Krems
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Elisabethinen
city: Linz
country: Austria
facility: Kepleruniversität Linz
city: Tulln
country: Austria
facility: Universitätsklinikum Tulln
city: Vöcklabruck
country: Austria
facility: Salzkammergut Klinikum Vöcklabruck
city: Wien
country: Austria
facility: Medizinische Universität Wien
city: Wien
country: Austria
facility: Krankenhaus Nord, Klinik Floridsdorf
Study officials:
References: