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

Recruiting

Who can join

Ages 18 and older · Women

Full eligibility criteria
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

About the study

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.

What is being tested

Sponsor: University of Miami · Participants: 40 · Started: Jul 1, 2021

Contact the study team

Official record on ClinicalTrials.gov — NCT04650256

Locations in the U.S.

FloridaUniversity of Miami, Miami

Conditions

From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.