Budesonide Foam Versus Placebo for Prevention of Acute Radiation Proctitis
Status and phase
Terminated
Phase 2
Conditions
Radiation Proctitis
Treatments
Drug: Placebo foam
Drug: budesonide
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
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.
Enrollment
17 patients
Sex
Male
Ages
18+ years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Prevention
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Quadruple Blind
17 participants in 2 patient groups, including a placebo group
1
Experimental group
Description:
2mg rectal budesonide per day for 8 weeks
Treatment:
Drug: budesonide
2
Placebo Comparator group
Description:
One application of placebo foam once daily for 8 weeks
Treatment:
Drug: Placebo foam
Trial contacts and locations
3
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Data sourced from clinicaltrials.gov
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