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

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

Recruiting
18 years and older
Female
Phase N/A

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Overview

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

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

Study details
    Skin Toxicity

NCT04650256

University of Miami

27 January 2024

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