Recruiting
Application of Chinese Herbal Complementary and Alternative Medicine (CAM) to Improve Human Health and to Further Botanical and Horticultural Sciences
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.
ClinicalTrials.gov IDNCT04650256
PhaseNA
Enrollment40
SponsorUniversity of Miami
Age18 Years
SexFEMALE
Conditions studied
Skin Toxicity
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.
Interventions
- Other: Complementary and alternative medicine (CAM) — CAM will be applied topically on the chest wall once during the day (or immediately after radiotherapy) and once at night daily.
Primary outcomes
- Proportion of patients free of clinically relevant skin toxicities (Up to 18 weeks.)
Eligibility information
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 locations
- University of Miami, Miami, Florida 33136 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.