Proctitis Radiation
Conditions
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.
Interventions
DRUGMMPF (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
OTHERPlacebo
4-day course of 6 tablets daily, followed by 4 tablets over the next 3 days followed by 2 tablets daily
Sponsors
Servier Affaires Médicales
Medical University Innsbruck
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
In this double blinded study Daflon and placebo are packed in the same manner, the blind is also protected by randomization. Only the principal investigator can break the blind in case of ethical or threatening patterns by contacting the sponsor and clinical research item.
Intervention model description
This is a multicenter, randomized, double-blind, placebo-controlled Phase III study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of necessary intervention | Day 1- Day 360 | Interventions to stop acute bleeding by chronic radiation proctitis: surgical, endoscopic or proctoscopic interventions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life of patients | Day 0 Day 180 Day 360 | 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. |
| Blood samples | Day 0-Day 360 | Differences in serum hemoglobin, thrombocytes, coagulation parameters (quick/pt=prothrombin time) |
| Stool | Day 0-Day 360 | Differences in calprotectin stool level |
| Presence of histological alterations | Day 0-Day 360 | Differences in histological alterations (distortion of crypts, Inflammation of crypts, fibrosis and ectasia of vessels, cytokines) |
Countries
Austria
Contacts
Primary ContactIrmgard Kronberger, MD
Backup ContactMarijana Ninkovic, MD
Outcome results
None listed