Budesonide Foam Versus Placebo for Prevention of Acute Radiation Proctitis

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00828230

Enrollment

Registered

2009-01-23

Start date

2008-09-30

Completion date

2011-10-31

Last updated

2012-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radiation Proctitis

Keywords

budesonide, placebo, acute radiation proctitis, late radiation proctitis, Prevention of acute radiation proctitis, Prevention of late radiation proctitis

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.

Interventions

DRUGbudesonide

One application of 2mg budesonide once daily for 8 weeks

DRUGPlacebo foam

One application of placebo foam once daily for 8 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026