?ydrocortisone enema in prevention of radiation-induced acute proctitis
Phase 2
- Conditions
- Radiation proctitis.Radiation proctitisK62.7
- Registration Number
- IRCT20230122057175N1
- Lead Sponsor
- Shiraz University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Age between 18-65 years old
ECOG performance score of 0-1
Newly diagnosed rectal cancer patient
Definitive histologic diagnosis
Exclusion Criteria
Not giving informed consent to much
Presence of chronic underlying hepatic, renal, and cardiac disorders
Previous history of malignancies
Previous history of pelvic radiotherapy
Presence of distant metastasis at the presentation
Synchronous malignant lesions of bowel at the presentation
Presence of bowel obstruction symptoms
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Severity of proctitis. Timepoint: The beginning of the study and the weekly during radiotherapy. Method of measurement: Based on Common Terminology Criteria for Adverse Events.;Severity of diarrhea. Timepoint: The beginning of the study and the weekly during radiotherapy. Method of measurement: Based on Common Terminology Criteria for Adverse Events.;Severity of rectal bleeding. Timepoint: The beginning of the study and the weekly during radiotherapy. Method of measurement: Based on Common Terminology Criteria for Adverse Events.;Severity of anal pain. Timepoint: The beginning of the study and the weekly during radiotherapy. Method of measurement: Based on Common Terminology Criteria for Adverse Events.;Severity of tenesmus. Timepoint: The beginning of the study and the weekly during radiotherapy. Method of measurement: Based on Common Terminology Criteria for Adverse Events.
- Secondary Outcome Measures
Name Time Method ???? ?? ??? ?????. Timepoint: Weekly during the radiotherapy. Method of measurement: Patient visit.