Application of Chinese Herbal Complementary and Alternative Medicine (CAM) to Improve Human Health and to Further Botanical and Horticultural Sciences

Study Overview
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Brief Summary
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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.

Official Title
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Application of Chinese Herbal Complementary and Alternative Medicine (CAM) to Improve Human Health and to Further Botanical and Horticultural Sciences

Conditions
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Skin Toxicity

Intervention / Treatment
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* Other: Complementary and alternative medicine (CAM)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CAM arm<br>Participants will be given the CAM intervention during scheduled, standard of care radiotherapy (up to 6 weeks) and 8-12 weeks (weeks 14-18) after radiotherapy. | Other: Complementary and alternative medicine (CAM)<br>* CAM will be applied topically on the chest wall once during the day (or immediately after radiotherapy) and once at night daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients free of clinically relevant skin toxicities | 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. | Up to 18 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SD-16 scores | 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. | Up to 18 weeks. | 
| Functional Assessment of Cancer Therapy-Breast (FACT-B) scores | 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. | Up to 18 weeks. | 
| High-sensitivity C-reactive protein (hsCRP) values | The inflammatory biomarker, plasma high-sensitivity C-reactive protein (hsCRP) will be evaluated using blood samples. | Up to 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, Radiotherapy, Complementary and alternative medicine