Clinical trial NCT00828230: Budesonide Foam Versus Placebo for Prevention of Acute Radiation Proctitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Radiation Proctitis
Keywords: budesonide
placebo
acute radiation proctitis
late radiation proctitis
Prevention of acute radiation proctitis
Prevention of late radiation proctitis
Lead sponsor: Dr. Falk Pharma GmbH
Sponsor class: INDUSTRY
First posted: 2009-01-23
Enrollment: 17
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Proportion of patients developing radiation proctitis during treatment or need rescue medication
timeFrame: within 8 weeks
Secondary outcomes:
measure: Time to occurrence of acute radiation proctitis
timeFrame: During 8 weeks
measure: Time to occurrence of chronic radiation proctitis
timeFrame: Within 1 year
measure: Adverse Events (AEs)
timeFrame: During 8 weeks of treatment
Other outcomes:
Locations:
city: Braunschweig
country: Germany
facility: Klinik für Radioonkologie und Strahlentherapie - Klinikum Braunschweig
city: Karlsruhe
country: Germany
facility: Strahlentherapie, St. Vincentius-Kliniken gAG
city: Trier
country: Germany
facility: Strahlentherapie, Klinikum Mutterhaus der Borromäerinnen
Study officials:
affiliation: Dr. Falk Pharma GmbH
name: Ralph Mueller, Dr
role: STUDY_DIRECTOR
References: