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

Not Applicable

Recruiting

• Conditions: Skin Toxicity
• Interventions: Other: Complementary and alternative medicine (CAM)

• Registration Number: NCT04650256
• Lead Sponsor: University of Miami

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-24
• Study First Submitted QC: 2020-11-24
• Study First Posted: 2020-12-02
• Study Start: 2021-07-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-27
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CAM arm	Complementary and alternative medicine (CAM)	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.

Primary Outcome Measures

Name	Time	Method
Proportion of patients free of clinically relevant skin toxicities	Up 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.

Secondary Outcome Measures

Name	Time	Method
SD-16 scores	Up to 18 weeks.	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.
Functional Assessment of Cancer Therapy-Breast (FACT-B) scores	Up to 18 weeks.	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.
High-sensitivity C-reactive protein (hsCRP) values	Up to 6 weeks	The inflammatory biomarker, plasma high-sensitivity C-reactive protein (hsCRP) will be evaluated using blood samples.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States