Application of Chinese Herbal Complementary and Alternative Medicine (CAM) to Improve Human Healt… (NCT04650256) | Clinical Trial Compass
RecruitingNot Applicable
Application of Chinese Herbal Complementary and Alternative Medicine (CAM) to Improve Human Health and to Further Botanical and Horticultural Sciences
United States40 participantsStarted 2021-07-01
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Proportion of patients free of clinically relevant skin toxicities