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

Skin Toxicity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04650256
• Other study ID #: 20200491
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2023
• Source: University of Miami
• Contact: Jennifer J Hu, PhD
• Phone: 3052437796
• Email: jhu[@]med.miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Skin Toxicity

Intervention

Other:
• Complementary and alternative medicine (CAM)
CAM will be applied topically on the chest wall once during the day (or immediately after radiotherapy) and once at night daily.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (3)

Lead Sponsor	Collaborator
University of Miami	Florida Breast Cancer Foundation, VAUGHN-JORDAN FOUNDATION, INC.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients free of clinically relevant skin toxicities	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.	Up to 18 weeks.
Secondary	SD-16 scores	Skindex 16 (SD-16) will be used to assess patients' self-assessment of skin effects. SD-16 has a total score ranging from 0-96 with a higher score indicating greater skin effects.	Up to 18 weeks.
Secondary	Functional Assessment of Cancer Therapy-Breast (FACT-B) scores	FACT-B in breast cancer patients will be used to obtain patient's self-assessment of health-related quality of life. FACT-B has a total score ranging from 0-148 with a higher score indicating a better quality of life.	Up to 18 weeks.
Secondary	High-sensitivity C-reactive protein (hsCRP) values	The inflammatory biomarker, plasma high-sensitivity C-reactive protein (hsCRP) will be evaluated using blood samples.	Up to 6 weeks