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

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.

Study Overview

• Status: Recruiting
• Conditions: Skin Toxicity
• Intervention / Treatment: Other: Complementary and alternative medicine (CAM)

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer J Hu, PhD; Phone Number: 3052437796; Email: jhu@med.miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami
      • Contact: Jennifer J Hu, PhD; Phone Number: 305-243-7796; Email: jhu@med.miami.edu
      • Principal Investigator: Jennifer J Hu, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CAM arm; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: Florida Breast Cancer Foundation; VAUGHN-JORDAN FOUNDATION, INC.
• Investigators: Principal Investigator: Jennifer J Hu, PhD, U. of Miami

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: November 24, 2020
• First Submitted That Met QC Criteria: November 24, 2020
• First Posted (Actual): December 2, 2020

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Breast cancer; Radiotherapy; Complementary and alternative medicine
• Other Study ID Numbers: 20200491

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No