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Application of Chinese Herbal Complementary and Alternative Medicine (CAM) to Improve Human Health and to Further Botanical and Horticultural Sciences

NCT04650256 · University of Miami
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

About this study
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.
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
Study design
Enrollment target: 40 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2021-07-01
Estimated completion: 2027-12-31
Last updated: 2026-03-27
Interventions
Other: Complementary and alternative medicine (CAM)
Primary outcomes
  • Proportion of patients free of clinically relevant skin toxicities (Up to 18 weeks.)
Sponsor
University of Miami · other
With: VAUGHN-JORDAN FOUNDATION, INC., Florida Breast Cancer Foundation
Contacts & investigators
ContactJennifer J Hu, PhD · contact · jhu@med.miami.edu · 3052437796
InvestigatorJennifer J Hu, PhD · principal_investigator, U. of Miami
All locations (1)
University of MiamiRecruiting
Miami, Florida, United States
Application of Chinese Herbal Complementary and Alternative Medicine (CAM) to Improve Human Health and to Further Botanical and Horticultural Sciences · TrialPath