RecruitingRecruiting
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