Radiation Proctitis MedDRA version: 8.1 Level: LLT Classification code 10036774 Term: Proctitis
Conditions
Interventions
Product Name: NABUREN Enema
Product Code: PMF 603
Pharmaceutical Form: Rectal solution
CAS Number: 156-54-7
Current Sponsor code: PMF603
Concentration unit: g gram(s)
Concentration type: equal
Concent
Sponsors
PROMEFARM
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Clinically localized prostate cancer with indication for radical CRT Histologically-confirmed adenocarcinoma of the prostate Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Total dose 70 Gy ICRU Life expectancy 5 years Serious systemic disease insulin treated diabetes mellitus etc Serious colonic disease inflammatory bowel disease Patients undergoing pelvic radiation Prior chemotherapy or pelvic radiation Distant metastases M0 Psychiatric illness Major rectal surgery Major ano-rectal disease eg, anal and rectal cancer Active anal fissures Ano-rectal fistulae Patients with previous anal sphincterotomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if prophylactic use of rectal butyrate reduces occurrence of radiation proctitis;Secondary Objective: To determine if prophylactic use of rectal butyrate reduces severity and/or duration of radiation proctitis;Primary end point(s): Duration of early RTOG/EORTC 1 proctitis. | — |
Countries
Italy
Outcome results
None listed