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| Name | Class |
|---|---|
| VAUGHN-JORDAN FOUNDATION, INC. | UNKNOWN |
| Florida Breast Cancer Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAM arm | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Complementary and alternative medicine (CAM) | Other | CAM will be applied topically on the chest wall once during the day (or immediately after radiotherapy) and once at night daily. |
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer J Hu, PhD | Contact | 3052437796 | jhu@med.miami.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jennifer J Hu, PhD | U. of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Recruiting | Miami | Florida | 33136 | United States |
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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 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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