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NCT Number: NCT04650256

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

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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Key information

Conditions

Skin Toxicity Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Location status: Recruiting

Location contact

Jennifer J Hu, PhD

CONTACT

[email protected]

305-243-7796

Jennifer J Hu, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Proportion of patients free of clinically relevant skin toxicities

    Time frame: Up to 18 weeks.

    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.

Secondary outcomes

  1. SD-16 scores

    Time frame: Up to 18 weeks.

    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.

  2. Functional Assessment of Cancer Therapy-Breast (FACT-B) scores

    Time frame: Up to 18 weeks.

    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.

  3. High-sensitivity C-reactive protein (hsCRP) values

    Time frame: Up to 6 weeks

    The inflammatory biomarker, plasma high-sensitivity C-reactive protein (hsCRP) will be evaluated using blood samples.

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer J Hu, PhD

CONTACT

[email protected]

3052437796

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Florida Breast Cancer Foundation
  • VAUGHN-JORDAN FOUNDATION, INC.

Registry information

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Dec 2, 2020
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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