The efficacy of sucralfate in prevention of acute proctitis induced by radiotherapy in cancer patients
Phase 2
- Conditions
- acute radiation proctitis.Radiation proctitis
- Registration Number
- IRCT201606042027N7
- Lead Sponsor
- Vice Chancellor for research of Mazandaran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Inclusion Criteria: patients aged older than 18 years; need for pelvic radiation.
Exclusion Criteria
Evidence of active infection; evidence of other sources of hematochezia including colon cancer, inflammatory bowel disease, and hemorrhoids; anal incontinence; anorectal fistula; anorectal stenosis; previous rectal surgery; pregnancy or breast feeding; female of child-bearing age who doesn't use a secure contraception method; known allergy to any ingredients of ointments; concurrent use of antibiotics or steroids
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Developement of proctitis. Timepoint: before intervention, then weekly for six weeks after intervention. Method of measurement: based on clinical presentation.;Proctitis severity. Timepoint: before intervention, then weekly for six weeks after intervention. Method of measurement: based on Radiation Therapy Oncology Group (RTOG) criteria.
- Secondary Outcome Measures
Name Time Method The effect of paroctitis on the lifestyle with a scoring system described by Kennedy et al, 2001. Timepoint: before intervention, then weekly for six weeks after intervention. Method of measurement: based on questionnaire.;Quantitative CRP. Timepoint: before intervention, then weekly for six weeks after intervention. Method of measurement: based on patient's blood sample.;Patient's psycho-social state. Timepoint: before intervention, then weekly for six weeks after intervention. Method of measurement: based on Hospital Anxiety-Deprresion (HAD) scale.