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Chinese Herbal Medicine for Skin Toxicity After Radiotherapy

This study is looking at a Chinese herbal Complementary and Alternative Medicine (CAM) product, which is an over-the-counter product with 1% menthol, to help with skin problems like pain and itching after radiation therapy (RT). The CAM will be applied to the chest wall twice a day. The study aims to see how many patients don't experience significant skin side effects. You might be able to join if you are a woman over 18 with newly diagnosed breast cancer (Stage II-IIIb), have had a mastectomy, and plan to receive radiation to your chest wall. The study is currently unclear on its recruitment status and plans to enroll 40 participants.

Study design
This is an interventional study with a planned enrollment of 40 participants. It is a single-arm study, meaning all participants will receive the same intervention.
What's involved
You would apply the CAM product topically on your chest wall once during the day (or immediately after radiotherapy) and once at night daily.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, freedom from clinically relevant skin toxicities, will be measured for up to 18 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04650256

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

Recruiting
NAAges 18+InterventionalSupportive care
University of Miami
~40 participants
Updated 2026-03-27 on ClinicalTrials.gov
What's tested:Complementary and alternative medicine (CAM)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of patients free of clinically relevant skin toxicities
Measured over Up to 18 weeks.

Conditions

Skin Toxicity

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Jennifer J Hu, PhD · PRINCIPAL_INVESTIGATOR · U. of Miami

Who to contact

Jennifer J Hu, PhD
[email protected]
3052437796
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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 this trial measures

  • Proportion of patients free of clinically relevant skin toxicitiesUp to 18 weeks.

    Clinically relevant skin toxicities - Grade 2 with moist desquamation or Grade 3 or higher using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) as evaluated by the treating clinician.