Status:
RECRUITING
Application of Chinese Herbal Complementary and Alternative Medicine (CAM) to Improve Human Health and to Further Botanical and Horticultural Sciences
Lead Sponsor:
University of Miami
Collaborating Sponsors:
VAUGHN-JORDAN FOUNDATION, INC.
Florida Breast Cancer Foundation
Conditions:
Skin Toxicity
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The purpose of this research is to study a Chinese herbal Complementary and Alternative Medicine (CAM) product for the temporary relief of pain and itching after radiotherapy (RT). This is an over-the...
Eligibility Criteria
Inclusion Criteria:
- Female subjects with newly diagnosed breast carcinoma
- > 18 years of age
- Post-mastectomy with or without reconstruction
- Stage II-IIIb with any receptor status
- All races and ethnicities are eligible
- Patients must be able to consent in English or Spanish
- Plan to receive adjuvant radiotherapy to the chest wall +/- regional lymph nodes
- RT will involve standard fractionation use of 3D conformal or Intensity-modulated RT (IMRT)
- Willing to sign protocol consent form
- Patients are allowed to receive adjuvant hormonal therapy and/or targeted therapies such as trastuzumab prior to, during and/or after radiation therapy.
- Patients may receive chemotherapy before or after radiation therapy
Exclusion Criteria:
- Prior radiation to the involved breast or chest wall
- Concurrent chemotherapy
- Unable or unwilling to sign informed consent
- Unable to speak English or Spanish
- Pregnant women
- Clinical or pathologic stage T4
- Metastatic disease
- Connective tissue disorder including Systemic Lupus Erythematosus and Scleroderma
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04650256
Start Date
July 1 2021
End Date
December 31 2027
Last Update
March 27 2026
Active Locations (1)
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1
University of Miami
Miami, Florida, United States, 33136