Actively Recruiting
Application of Chinese Herbal Complementary and Alternative Medicine (CAM) to Improve Human Health and to Further Botanical and Horticultural Sciences
Led by University of Miami · Updated on 2026-03-27
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Miami
Lead Sponsor
V
VAUGHN-JORDAN FOUNDATION, INC.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying a Chinese herbal Complementary and Alternative Medicine (CAM) product containing 1% menthol to help temporarily relieve pain and itching after radiotherapy in female patients with newly diagnosed breast cancer. The study focuses on skin toxicity that can occur during and after radiotherapy treatment. This trial is interventional and sponsored by the University of Miami. Participants will apply the CAM product topically on the chest wall once a day and once at night during their standard radiotherapy course, which lasts up to 6 weeks. Treatment with the CAM product continues for an additional 8 to 12 weeks (weeks 14 to 18) after completing radiotherapy. This regimen aims to assess the product's ability to reduce skin-related side effects. During the study, participants will be monitored for skin toxicities up to 18 weeks, using measures such as the proportion of patients free from significant skin problems, SD-16 scores, FACT-B quality of life scores, and high-sensitivity C-reactive protein levels up to 6 weeks. The study involves regular assessments of symptoms and skin condition, with all study-related care provided under medical supervision throughout the treatment and follow-up periods.
CONDITIONS
Brief Title
Application of Chinese Herbal Complementary and Alternative Medicine (CAM) to Improve Human Health and to Further Botanical and Horticultural Sciences
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female subjects with newly diagnosed breast carcinoma
- Over 18 years of age
- Post-mastectomy with or without reconstruction
- Stage II-IIIb breast cancer with any receptor status
- All races and ethnicities are eligible
- Able to consent in English or Spanish
- Planned adjuvant radiotherapy to the chest wall with or without regional lymph nodes
- Radiotherapy involves standard fractionation using 3D conformal or IMRT
- Willing to sign protocol consent form
- Allowed to receive adjuvant hormonal therapy and/or targeted therapies such as trastuzumab before, during, or after radiotherapy
- May receive chemotherapy before or after radiotherapy
You will not qualify if you...
- 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 breast cancer
- Metastatic disease
- Connective tissue disorders including Systemic Lupus Erythematosus and Scleroderma
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 6 weeks during radiotherapy plus 8 to 12 weeks post-radiotherapy (weeks 14-18)
Participants apply complementary and alternative medicine (CAM) topically on the chest wall once during the day (or immediately after radiotherapy) and once at night daily during scheduled standard radiotherapy and for 8-12 weeks after radiotherapy.
Visits coincide with standard radiotherapy schedule and additional assessments up to 18 weeks
Trial Site Locations
Total: 1 location
1
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
J
Jennifer J Hu, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
Frequently Asked Questions
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