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RecruitingInterventional

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

NCT ID: NCT04650256Sponsor: University of MiamiLast updated: 2026-03-27

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.

Arms & interventions

  • OtherComplementary and alternative medicine (CAM)

    CAM will be applied topically on the chest wall once during the day (or immediately after radiotherapy) and once at night daily.

Outcome measures

Primary

  • 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.

    Time frame: Up to 18 weeks.

Secondary

  • SD-16 scores

    Time frame: Up to 18 weeks.

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

    Time frame: Up to 18 weeks.

  • High-sensitivity C-reactive protein (hsCRP) values

    Time frame: Up to 6 weeks

Eligibility criteria

Sex: FemaleAge: 18 Years and olderHealthy volunteers: No
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 locations (1)

University of Miami

Miami, Florida, 33136

Recruiting
Jennifer J Hu, PhD · Contact
305-243-7796jhu@med.miami.edu
Jennifer J Hu, PhD · Principal Investigator