Budesonide Foam Versus Placebo for Prevention of Acute Radiation Proctitis

• Status: Terminated
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr. Falk Pharma GmbH
• Treatments: Budesonide

Criteria

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