Evaluation of the effects of Aloe Vera Ointment in the radiation induced Proctitis in prostate cancer patients
Phase 3
Recruiting
- Conditions
- Radiation-induced acute proctitis in prostate cancer patients.Radiation proctitisK62.7
- Registration Number
- IRCT20090613002027N17
- Lead Sponsor
- Sari University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 56
Inclusion Criteria
Being over 18 years old
Prostate cancer patients whom are under pelvic Radiotherapy
Exclusion Criteria
Evidence of active infection
Evidence suggesting other causes of bloody diarrhea, such as colon cancer, inflammatory bowel disease and hemorrhoids
Fecal Incontinence
Anorectal fistula
Anal Stenosis
History of surgery in the rectum area
Any known Sensitivity of the components used in the ointment
Concomitant use of antibiotics, Glucocorticoids and Sulfonamide compounds
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Development of Proctitis. Timepoint: Before intervention, then every 2 weeks for eight weeks after intervention. Method of measurement: Based on clinical presentation.;Proctitis severity. Timepoint: Before intervention, then every 2weeks for eight weeks after intervention. Method of measurement: Based on Radiation therapy oncology group (RTOG) and CTCAE–v5-2017 criteria.
- Secondary Outcome Measures
Name Time Method Social-Psychological state. Timepoint: Before intervention, then every 2weeks for eight weeks after intervention. Method of measurement: Based on Hospital Anxiety-Deprresion (HAD) scale.;Quality of life. Timepoint: Before intervention, then every 2weeks for eight weeks after intervention. Method of measurement: Based on questionnaire defines the Quality of Life from 0 to 5.