Proctitis RadiationPhase 3MiFlaPRONCT04335617
Micronized Purified Flavonoid- Fraction (MPFF) in the Management of Radiation Proctitis
A Phase 3 study testing MMPF (Micronized purified Flavonoid-Fraction) in people with Proctitis Radiation, run by Medical University Innsbruck at 11 sites in Austria.
Trial summary
national and multi-center trial for medical therapy of chronic radiation proctitis inducing anorectal bleedings Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proctitis Radiation
- What is being tested?
- MMPF (Micronized purified Flavonoid-Fraction)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 11 sitesAustria
- Study dates
- 26 Feb 2020to 26 Aug 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
11 sites in 1 country.
11 sites in 1 country
Austria11 sites, 11 recruiting
- Not yet recruiting
Krankenhaus der Stadt Dornbirn
Dornbirn, 6850
Clemens Obwegeser, Dr.
- Recruiting
Barmherzige Brüder Krankenhaus Graz
Graz, 8020
Martin Mitteregger, Dr.
- Recruiting
Medizinische Universität Graz
Graz, 8036
Martina Lemmerer, Dr.
- Recruiting
Medizinische Universität Innsbruck
Innsbruck, Tyrol, 6020
Irmgard E Kronberger, MD, irmgard.kronberger@i-med.ac.at
- Recruiting
Universitätsklinikum Krems
Krems, 3500
Stefan Sattler, Dr.
- Recruiting
Ordensklinikum Linz GmbH Elisabethinen
Linz, 4020
Ulrike Enkner, Dr.
- Recruiting
Kepleruniversität Linz
Linz, 4040
Günther Klimbacher, Dr.
- Recruiting
Universitätsklinikum Tulln
Tulln, 3430
Alf-Dorian Binder, Dr.
- Recruiting
Medizinische Universität Wien
Vienna, 1090
Stefan Riss, Assoc.-Prof.
- Recruiting
Krankenhaus Nord, Klinik Floridsdorf
Vienna, 1210
Zacaria Sow, Dr.
- Recruiting
Salzkammergut Klinikum Vöcklabruck
Vöcklabruck, 4840
Raimund Strouhal, Dr.
About this study
Official title: 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
Read the 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
- Being tested
- MMPF (Micronized purified Flavonoid-Fraction), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMPF (Micronized purified Flavonoid-Fraction)Drug
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
PlaceboOther
4-day course of 6 tablets daily, followed by 4 tablets over the next 3 days followed by 2 tablets daily
| Study group | Role | What they receive |
|---|---|---|
| Investigational | Experimental | Patients receive MMPF 500mg for one year Receives: Drug: MMPF (Micronized purified Flavonoid-Fraction) |
| Placebo | Placebo comparator | Patients receive Placebo for one year Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of necessary intervention
Interventions to stop acute bleeding by chronic radiation proctitis: surgical, endoscopic or proctoscopic interventions
Measured: Day 1- Day 360
Secondary outcomes (4)
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.
Measured: Day 0 Day 180 Day 360
Blood samples
Differences in serum hemoglobin, thrombocytes, coagulation parameters (quick/pt=prothrombin time)
Measured: Day 0-Day 360
Stool
Differences in calprotectin stool level
Measured: Day 0-Day 360
Presence of histological alterations
Differences in histological alterations (distortion of crypts, Inflammation of crypts, fibrosis and ectasia of vessels, cytokines)
Measured: Day 0-Day 360
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start26 Feb 2020
- Primary completion26 Feb 2023 (estimated)
- Study completion26 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proctitis RadiationStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a multicenter, randomized, double-blind, placebo-controlled Phase III study.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Collaborators
- Servier Affaires Médicales
- Responsible party
- Principal investigator, Irmgard E Kronberger, MD, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04335617
- Sponsor's protocol ID
- MiFlaPRO_2019
- Acronym
- MiFlaPRO
- Status last verified
- Oct 2020
- First submitted
- 13 Dec 2019
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double Blind Placebo Controlled Trial of Micronized Purified Flavonoid- Fraction (MPFF) in the Management of Radiation Proctitis
- ClinicalTrials.gov ID
- NCT04335617
- Acronym / sponsor ID
- MiFlaPRO / MiFlaPRO_2019
- Conditions
- Proctitis Radiation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Collaborators
- Servier Affaires Médicales
- Study start
- 26 Feb 2020 (actual)
- Primary completion
- 26 Feb 2023 (estimated)
- Study completion
- 26 Aug 2023 (estimated)
- First posted
- 6 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a multicenter, randomized, double-blind, placebo-controlled Phase III study.
| Arm | Type | Receives |
|---|---|---|
| Investigational | Experimental | Drug: MMPF (Micronized purified Flavonoid-Fraction)Patients receive MMPF 500mg for one year |
| Placebo | Placebo comparator | Other: PlaceboPatients receive Placebo for one year |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | Investigational |
| Placebo4-day course of 6 tablets daily, followed by 4 tablets over the next 3 days followed by 2 tablets daily | Other | Placebo |
Primary outcome
Number of necessary intervention
Time frame: Day 1- Day 360
Interventions to stop acute bleeding by chronic radiation proctitis: surgical, endoscopic or proctoscopic interventions
4 secondary outcomes
Quality of life of patients
Time frame: Day 0 Day 180 Day 360
Blood samples
Time frame: Day 0-Day 360
Stool
Time frame: Day 0-Day 360
Presence of histological alterations
Time frame: Day 0-Day 360
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MMPF (Micronized purified Flavonoid-Fraction) in people with Proctitis Radiation, run by Medical University Innsbruck at 11 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Irmgard Kronberger, MD (+43 512 504 ext. 0, irmgard.kronberger@i-med.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of necessary intervention (time frame: Day 1- Day 360). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020.