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

University of Miami

Status: Enrolling

Conditions: Skin Toxicity

Treatments: Other: Complementary and alternative medicine (CAM)

Study type: Interventional

Funder types: Other

Identifiers

NCT04650256

20200491

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 1 patient group

CAM arm

Experimental group

Description:

Participants will be given the CAM intervention during scheduled, standard of care radiotherapy (up to 6 weeks) and 8-12 weeks (weeks 14-18) after radiotherapy.

Treatment:

Other: Complementary and alternative medicine (CAM)