Skin Toxicity
Conditions
Keywords
Breast cancer, Radiotherapy, Complementary and alternative medicine
Brief 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.
Interventions
OTHERComplementary 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.
Sponsors
University of Miami
VAUGHN-JORDAN FOUNDATION, INC.
Florida Breast Cancer Foundation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients free of clinically relevant skin toxicities | Up to 18 weeks. | Clinically relevant skin toxicities - Grade 2 with moist desquamation or Grade 3 or higher using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) as evaluated by the treating clinician. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SD-16 scores | Up to 18 weeks. | Skindex 16 (SD-16) will be used to assess patients' self-assessment of skin effects. SD-16 has a total score ranging from 0-96 with a higher score indicating greater skin effects. |
| Functional Assessment of Cancer Therapy-Breast (FACT-B) scores | Up to 18 weeks. | FACT-B in breast cancer patients will be used to obtain patient's self-assessment of health-related quality of life. FACT-B has a total score ranging from 0-148 with a higher score indicating a better quality of life. |
| High-sensitivity C-reactive protein (hsCRP) values | Up to 6 weeks | The inflammatory biomarker, plasma high-sensitivity C-reactive protein (hsCRP) will be evaluated using blood samples. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJennifer J Hu, PhD
U. of Miami
CONTACTJennifer J Hu, PhD
Outcome results
None listed