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

Last updated: February 25, 2025
Sponsor: University of Miami
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Complementary and alternative medicine (CAM)

Clinical Study ID

NCT04650256
20200491
  • Ages > 18
  • Female

Study 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

Inclusion

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 therapiessuch as trastuzumab prior to, during and/or after radiation therapy.

  • Patients may receive chemotherapy before or after radiation therapy

Exclusion

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 Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Complementary and alternative medicine (CAM)
Phase:
Study Start date:
July 01, 2021
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • University of Miami

    Miami, Florida 33136
    United States

    Active - Recruiting

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