Budesonide Foam Versus Placebo for Prevention of Acute Radiation Proctitis

Study Overview
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Brief Summary
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To proof the superiority of an 8-week rectal treatment with once-daily 2 mg budesonide versus placebo for the prevention of acute radiation proctitis, and to evaluate the occurrence of chronic radiation proctitis 1 year after start of radiation therapy.

Official Title
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Randomised, Double-blind, Placebo-controlled, Multicentre, Comparative Phase II Pilot Study on the Efficacy and Tolerability of an 8-week Rectal Treatment With 2 mg Budesonide or Placebo for the Prevention of Acute Radiation Proctitis

Conditions
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Radiation Proctitis

Intervention / Treatment
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* Drug: budesonide
* Drug: Placebo foam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent, Men aged at least 18 years, Patients with ECOG performance status <= 2 or Karnofsky Performance Status Scale >= 70%, Estimated life expectancy more than 3 years, Diagnosis of prostate carcinoma, Indication for local RT in patients with prostatic cancer. Exclusion Criteria: Crohn's disease, indeterminate colitis, ulcerative colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis), Severe or symptomatic ischaemic colitis at baseline, Grade III internal haemorrhoids at baseline, High risk patients needing extended radiation therapy, Acute EORTC/RTOG lower GI toxicity score of >=1 at baseline, Bacterial, amoebic, fungal, or viral infections of the gut, Tuberculosis, hypertension, infection, diabetes mellitus (included familiarly predisposition), active peptic ulcer, osteoporosis, glaucoma, or cataract, if careful medical monitoring is not ensured, Portal hypertension or liver cirrhosis, Abnormal hepatic function (ALT, AST or AP > 2.5 x ULN), Known intolerance/hypersensitivity/resistance to study drug or drugs of similar chemical structure or pharmacological profile, or to any of the other constituents of the study drug, Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>2mg rectal budesonide per day for 8 weeks | Drug: budesonide<br>* One application of 2mg budesonide once daily for 8 weeks<br>* Other names: Budenofalk rectal foam;|
| Placebo Comparator: 2<br>One application of placebo foam once daily for 8 weeks | Drug: Placebo foam<br>* One application of placebo foam once daily for 8 weeks<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients developing radiation proctitis during treatment or need rescue medication |  | within 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to occurrence of acute radiation proctitis |  | During 8 weeks | 
| Time to occurrence of chronic radiation proctitis |  | Within 1 year | 
| Adverse Events (AEs) |  | During 8 weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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budesonide, placebo, acute radiation proctitis, late radiation proctitis, Prevention of acute radiation proctitis, Prevention of late radiation proctitis