Breast Cancer Clinical Trial

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

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.

View Eligibility Criteria

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

Study is for people with:

Breast Cancer

Estimated Enrollment:

28

Study ID:

NCT04650256

Recruitment Status:

Recruiting

Sponsor:

University of Miami

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There is 1 Location for this study

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University of Miami
Miami Florida, 33136, United States More Info
Jennifer J Hu, PhD
Contact
305-243-7796
[email protected]
Jennifer J Hu, PhD
Principal Investigator

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Study is for people with:

Breast Cancer

Estimated Enrollment:

28

Study ID:

NCT04650256

Recruitment Status:

Recruiting

Sponsor:


University of Miami

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