Radiation-induced acute proctitis in prostate cancer patients. Radiation proctitis
Conditions
Interventions
Intervention 1: Intervention group: Aloe Vera ointment 3% for the first day of radiotherapy every 12 hours, rectal use for 2 months. Intervention 2: Control group: Placebo of Aloe Vera ointment 3% for
Sponsors
Sari University of Medical Sciences
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Being over 18 years old Prostate cancer patients whom are under pelvic Radiotherapy
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactEbrahim Salehifar
Sari University of Medical Sciences
Outcome results
None listed