Application of Chinese Herbal Complementary and Alternative Medicine (CAM) to Improve Human Health and to Further Botanical and Horticultural Sciences
Recruiting · NCT04650256 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Miami
View the official record on ClinicalTrials.gov →Interventions studied
Complementary and alternative medicine (CAM)
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- University of Miami - Miami, Florida, United States