Application of Chinese Herbal Complementary and Alternative Medicine (CAM) to Improve Human Health and to Further Botanical and Horticultural Sciences
Recruiting now · Not applicable
Conditions studied: Skin Toxicity
In brief
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.
Key facts
- Study ID
- NCT04650256
- Run by
- University of Miami
- People needed
- 40
- Starts
- 2021-07-01
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2026-03-27
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Miami — Miami, Florida, United States (enrolling)
Full record on ClinicalTrials.gov
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