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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a Chinese herbal product for short-term relief of pain and itching after radiation treatment. The product is sold without a prescription and contains 1% menthol as an active ingredient. The study is for women with newly diagnosed breast cancer who have had a breast removed and plan to have radiation.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Women older than 18 with newly diagnosed breast cancer.
  • Have had surgery to remove a breast, with or without surgery to rebuild it.
  • Have stage II–IIIb breast cancer, with any receptor status (markers that help guide treatment).
  • People of all races and ethnic backgrounds may join.
  • Can give consent in English or Spanish and are willing to sign the study consent form.
  • Plan to have radiation to the chest wall, with or without nearby lymph nodes, after surgery.
  • Radiation must use a standard dose schedule with 3D conformal treatment or intensity-modulated radiation therapy (IMRT).
  • Hormone therapy or targeted drugs, such as trastuzumab, are allowed before, during, or after radiation. Chemotherapy is allowed before or after radiation.

Who can't join

  • Have had radiation to the affected breast or chest wall before.
  • Are receiving chemotherapy during radiation.
  • Cannot or will not sign the study consent form.
  • Cannot speak English or Spanish.
  • Are pregnant.
  • Have a tumor classified as T4 based on an exam or tissue testing.
  • Have cancer that has spread to distant parts of the body.
  • Have a connective tissue disorder, such as lupus or scleroderma, that affects tissues supporting the body.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 sites (1)

FL