Application of Chinese Herbal Complementary and Alternative Medicine (CAM) to Improve Human Health and to Further Botanical and Horticultural Sciences
- Conditions
- Skin Toxicity
- Registration Number
- NCT04650256
- Lead Sponsor
- University of Miami
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 40
Inclusion Criteria:<br><br> - Female subjects with newly diagnosed breast carcinoma<br><br> - > 18 years of age<br><br> - Post-mastectomy with or without reconstruction<br><br> - Stage II-IIIb with any receptor status<br><br> - All races and ethnicities are eligible<br><br> - Patients must be able to consent in English or Spanish<br><br> - Plan to receive adjuvant radiotherapy to the chest wall +/- regional lymph nodes<br><br> - RT will involve standard fractionation use of 3D conformal or Intensity-modulated RT<br> (IMRT)<br><br> - Willing to sign protocol consent form<br><br> - Patients are allowed to receive adjuvant hormonal therapy and/or targeted therapies<br> such as trastuzumab prior to, during and/or after radiation therapy.<br><br> - Patients may receive chemotherapy before or after radiation therapy<br><br>Exclusion Criteria:<br><br> - Prior radiation to the involved breast or chest wall<br><br> - Concurrent chemotherapy<br><br> - Unable or unwilling to sign informed consent<br><br> - Unable to speak English or Spanish<br><br> - Pregnant women<br><br> - Clinical or pathologic stage T4<br><br> - Metastatic disease<br><br> - Connective tissue disorder including Systemic Lupus Erythematosus and Scleroderma
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients free of clinically relevant skin toxicities
- Secondary Outcome Measures
Name Time Method SD-16 scores;Functional Assessment of Cancer Therapy-Breast (FACT-B) scores;High-sensitivity C-reactive protein (hsCRP) values
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