Effects of topical vitamin E solution in mucositis
Phase 3
Recruiting
- Conditions
- Oral mucositis.Oral mucositis (ulcerative)
- Registration Number
- IRCT20180416039325N1
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
Age older than 18 years
Receiving conditioning regimen with Busulfan and Cyclophosphamide
Exclusion Criteria
Showing active mucositis signs and symptoms at the time of admission
Active bleeding
Any contraindication to vitamin E as hypersensitivity reactions
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of oral mucositis. Timepoint: Daily for 15 days which is the duration that patient receives the formulation. Method of measurement: Clinical evaluation based on National Cancer Institute Common Terminology Criteria for Adverse Effects version 4.0 scale.;Severity of oral mucositis. Timepoint: Daily for 15 days which is the duration that patient receives the formulation. Method of measurement: Clinical evaluation based on National Cancer Institute Common Terminology Criteria for Adverse Effects version 4.0 scale.
- Secondary Outcome Measures
Name Time Method Duration of Bone Marrow Transplant ward stay. Timepoint: From the day of admission to Bone Marrow Transplant ward until discharge form the ward. Method of measurement: Medical records.;The need for narcotic analgesic. Timepoint: From the day of admission to Bone Marrow Transplant ward until discharge form the ward. Method of measurement: Medical records.