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NCT04650256NARecruiting

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

University of Miami

Start Date

7/1/2021

Completion Date

12/31/2027

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

OTHER

Complementary and alternative medicine (CAM)

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Conditions

Skin Toxicity

Locations

University of Miami

Miami, Florida 33136

United States