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

Sponsor

University of Miami (Other)

Overall Status

Recruiting

CT.gov ID

NCT04650256

Collaborator

VAUGHN-JORDAN FOUNDATION, INC. (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Skin Toxicity	Other: Complementary and alternative medicine (CAM)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

28 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jul 1, 2021

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Miami	Miami	Florida	United States	33136

Sponsors and Collaborators

University of Miami
VAUGHN-JORDAN FOUNDATION, INC.

Investigators

Principal Investigator: Jennifer J Hu, PhD, U. of Miami

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jennifer Hu, Professor, University of Miami

ClinicalTrials.gov Identifier:

NCT04650256

Other Study ID Numbers:

20200491

First Posted:

Dec 2, 2020

Last Update Posted:

Dec 1, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Jennifer Hu, Professor, University of Miami

Breast cancer

Radiotherapy

Complementary and alternative medicine

Study Results

No Results Posted as of Dec 1, 2021