Using Chinese herbal medicine to relieve skin toxicity after breast cancer radiotherapy
Official title: Application of Chinese Herbal Complementary and Alternative Medicine (CAM) to Improve Human Health and to Further Botanical and Horticultural Sciences
Run by University of Miami · NCT04650256 · Data updated 2026-11-12
This study is testing if a Chinese herbal medicine with menthol can help relieve pain and itching in women who have breast cancer and are experiencing skin issues after radiation treatment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 40 (estimated) |
| Sponsor | University of Miami Academic / other |
| Drugs / interventions | trastuzumab, chemotherapy, radiation |
| Locations | 1 site (Miami, Florida) |
| Status | Recruiting |
| Started | July 1, 2021 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | March 27, 2026 |
| Trial ID | NCT04650256 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are female patients over 18 years old with newly diagnosed stage II-IIIb breast carcinoma who are planning to receive adjuvant radiotherapy.
✕Probably not a fit
Patients who have prior radiation to the involved breast or chest wall, or those with metastatic disease, are unlikely to benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This research investigates the effectiveness of a Chinese herbal Complementary and Alternative Medicine (CAM) product, which contains 1% menthol, in alleviating pain and itching associated with skin toxicity following radiotherapy in female patients with newly diagnosed breast cancer. The study targets women who have undergone mastectomy and are scheduled to receive adjuvant radiotherapy. Participants will be monitored for their response to the CAM treatment during their radiotherapy regimen. The study aims to provide insights into the potential benefits of herbal remedies in managing side effects of cancer treatment.
Why it matters
Potential benefit: If successful, this study could provide a new, effective option for managing skin toxicity and improving the quality of life for breast cancer patients undergoing radiotherapy.
How similar studies have gone: While the use of CAM in cancer treatment is gaining interest, this specific approach using Chinese herbal medicine for skin toxicity relief after radiotherapy is relatively novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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University of Miami
Miami, Florida, United States Recruiting
Study contacts
- Principal investigator: Jennifer J Hu, PhD — U. of Miami
- Study coordinator: Jennifer J Hu, PhD
- Email: jhu@med.miami.edu
- Phone: 3052437796
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.