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

University of Miami1 site in 1 country40 target enrollmentJuly 1, 2021

ConditionsSkin Toxicity

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Skin Toxicity
Sponsor: University of Miami
Enrollment: 40
Locations: 1
Primary Endpoint: Proportion of patients free of clinically relevant skin toxicities
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 1, 2021

End Date

December 31, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

University of Miami

Responsible Party

Principal Investigator

Jennifer Hu

Professor

University of Miami

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.

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

Outcomes

Primary Outcomes

Proportion of patients free of clinically relevant skin toxicities

Time Frame: 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.