Budesonide Foam Versus Placebo for Prevention of Acute Radiation Proctitis

Phase 2

Terminated

• Conditions: Radiation Proctitis
• Interventions: Drug: budesonide; Drug: Placebo foam

• Registration Number: NCT00828230
• Lead Sponsor: Dr. Falk Pharma GmbH

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2009-01-22
• Study First Submitted QC: 2009-01-22
• Study First Posted: 2009-01-23
• Primary Completion: 2011-08
• Study Completion: 2011-10
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-26
• Last Update Posted: 2012-01-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	budesonide	2mg rectal budesonide per day for 8 weeks
2	Placebo foam	One application of placebo foam once daily for 8 weeks

Primary Outcome Measures

Name	Time	Method
Proportion of patients developing radiation proctitis during treatment or need rescue medication	within 8 weeks

Secondary Outcome Measures

Name	Time	Method
Adverse Events (AEs)	During 8 weeks of treatment
Time to occurrence of acute radiation proctitis	During 8 weeks
Time to occurrence of chronic radiation proctitis	Within 1 year

Trial Locations

Locations (3)

Klinik für Radioonkologie und Strahlentherapie - Klinikum Braunschweig; 🇩🇪 Braunschweig, Germany

Strahlentherapie, St. Vincentius-Kliniken gAG; 🇩🇪 Karlsruhe, Germany

Strahlentherapie, Klinikum Mutterhaus der Borromäerinnen; 🇩🇪 Trier, Germany