Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
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.
Phase
N/A
Funding Agency/Sponsor
Institutional
Disease
Population Sciences
Enrollment Eligibility
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