NCT04650256 Application of Chinese Herbal Complementary and Alternative Medicine (CAM) to Improve Human Health and to Further Botanical and Horticultural Sciences
| NCT ID | NCT04650256 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Miami |
| Condition | Skin Toxicity |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2021-07-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2021-07-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Jennifer J Hu, PhD
PRINCIPAL INVESTIGATOR
U. of Miami
Frequently Asked Questions
Who can join the NCT04650256 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Skin Toxicity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04650256 currently recruiting?
Yes, NCT04650256 is actively recruiting participants. Contact the research team at jhu@med.miami.edu for enrollment information.
Where is the NCT04650256 trial being conducted?
This trial is being conducted at Miami, United States.
Who is sponsoring the NCT04650256 clinical trial?
NCT04650256 is sponsored by University of Miami. The principal investigator is Jennifer J Hu, PhD at U. of Miami. The trial plans to enroll 40 participants.