Chinese Herbal Medicine for Skin Toxicities
Trial Summary
What is the purpose of this trial?
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-counter product with 1% menthol as an active ingredient.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it allows for the use of adjuvant hormonal therapy and targeted therapies like trastuzumab, and chemotherapy can be given before or after radiation therapy.
What data supports the effectiveness of the Chinese Herbal CAM Product treatment for skin toxicities?
A study on Compound Danxiong Granules, a similar Chinese herbal treatment, showed it effectively reduced skin toxicities caused by cancer therapies, with a 77.61% success rate compared to 27.27% for a placebo. This suggests that Chinese herbal treatments can be effective for managing skin issues.12345
Is Chinese herbal medicine generally safe for humans?
How does the Chinese herbal treatment for skin toxicities differ from other treatments?
This Chinese herbal treatment is unique because it uses a combination of herbs applied topically to reduce skin toxicities, particularly those caused by cancer therapies. Unlike conventional treatments, it focuses on a multi-herb approach to target multiple pathways in the body, potentially reducing side effects and improving safety.2341011
Research Team
Jennifer J Hu, PhD
Principal Investigator
U. of Miami
Eligibility Criteria
This trial is for women over 18 with newly diagnosed breast carcinoma stages II-IIIb, planning to receive standard radiotherapy post-mastectomy. Participants can consent in English or Spanish and may have had chemotherapy before or after radiation but not concurrently. Pregnant women, those who've had prior chest radiation, metastatic disease, certain connective tissue disorders, or cannot consent are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Radiotherapy
Participants receive standard of care radiotherapy while using the CAM product for temporary relief of pain and itching
Post-radiotherapy Treatment
Participants continue using the CAM product for 8-12 weeks after radiotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Chinese Herbal CAM Product
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Miami
Lead Sponsor
Florida Breast Cancer Foundation
Collaborator
Florida Breast Cancer Foundation
Collaborator
VAUGHN-JORDAN FOUNDATION, INC.
Collaborator