Alpha ointment (Henna) and hydrocortisone in radiation-induced dermatitis
Phase 2
- Conditions
- severity of radiation - induced skin reaction.RadiodermatitisL58.0, L58
- Registration Number
- IRCT201206099979N1
- Lead Sponsor
- Vice chancellor for research,, Shiraz University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 60
Inclusion Criteria
Eligible patients had to have newly pathologically proven diagnosed locally advanced breast cancer treated with modified radical mastectomy followed by sequential adjuvant chemotherapy and chest wall radiotherapy (45-50.4 Gy), and developed grade 2 and/or 3 radiation-induced dermatitis.
Exclusion criteria:
1. Any history of collagen vascular diseases, or diabetes mellitus,
2. Taking any drugs interacting wound healing process, like systemic steroids,
3. Previous history of chest wall radiotherapy and
4. Concurrent use of chemotherapy.
All patients had to sign a consent form approved by the local research ethics committee before participating in the study.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Severity of radiation-induced skin reaction. Timepoint: Just before intervention and then weekly for 4 weeks. Method of measurement: Dermatitis area (cm2) were measured (by grid paper) and estimated.
- Secondary Outcome Measures
Name Time Method