A Phase 3 interventional study of MMPF (Micronized purified Flavonoid-Fraction) and Placebo in Proctitis Radiation, sponsored by Medical University Innsbruck. Status unknown at 11 sites in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-03.
Sponsored by Medical University Innsbruck · Phase 3, Interventional, and Treatment
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.
27 studies on the registry are indexed under Proctitis; 6 are open to participants now.
This study's planned enrollment of 200 is above the median of 122 across 23 interventional studies indexed under Proctitis.
Browse Proctitis studies →Medical University Innsbruck is the lead sponsor of 186 studies on the registry; 47 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive MMPF 500mg for one year
Drug: MMPF (Micronized purified Flavonoid-Fraction)
Patients receive Placebo for one year
Other: Placebo
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
Number of necessary intervention
Interventions to stop acute bleeding by chronic radiation proctitis: surgical, endoscopic or proctoscopic interventions
Time frame: Day 1- Day 360
Quality of life of patients
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.
Time frame: Day 0 Day 180 Day 360
Blood samples
Differences in serum hemoglobin, thrombocytes, coagulation parameters (quick/pt=prothrombin time)
Time frame: Day 0-Day 360
Stool
Differences in calprotectin stool level
Time frame: Day 0-Day 360
Presence of histological alterations
Differences in histological alterations (distortion of crypts, Inflammation of crypts, fibrosis and ectasia of vessels, cytokines)
Time frame: Day 0-Day 360
This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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