The efficacy of topical Alpha ointment (containing natural Henna) on healing of radiation-induced dermatitis in breast cancer patients
Phase 2
Recruiting
- Conditions
- Breast cancerCancer - Breast
- Registration Number
- ACTRN12612000837820
- Lead Sponsor
- Shiraz University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 60
Inclusion Criteria
Eligible patients have 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
Exclusion criteria were any history of collagen vascular diseases, diabetes mellitus, taking any drugs interacting wound healing process, like systemic steroids, previous history of chest wall radiotherapy and concurrent use of chemotherapy. All patients had to sign a consent form approved by the local research ethics committee before participating in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint of the study is the rate of healing of radiation dermatitis.[Dermatitis grade will be determined according to the Common Terminology Criteria for Adverse Events version 4.0. The dermatitis area (cm2) will be measured independently by 2 physicians in each exam (weekly) till 4 weeks after starting intervention.]
- Secondary Outcome Measures
Name Time Method il[Nil]