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

NCT ID: NCT04650256

Last Updated: 2025-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2025-12-31

Brief Summary

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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

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Conditions

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Skin Toxicity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Complementary and alternative medicine (CAM)

Intervention Type OTHER

CAM will be applied topically on the chest wall once during the day (or immediately after radiotherapy) and once at night daily.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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VAUGHN-JORDAN FOUNDATION, INC.

UNKNOWN

Sponsor Role collaborator

Florida Breast Cancer Foundation

OTHER

Sponsor Role collaborator

University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Jennifer Hu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jennifer J Hu, PhD

Role: PRINCIPAL_INVESTIGATOR

U. of Miami

Locations

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University of Miami

Miami, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jennifer J Hu, PhD

Role: CONTACT

3052437796

Facility Contacts

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Jennifer J Hu, PhD

Role: primary

305-243-7796

Other Identifiers

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20200491

Identifier Type: -

Identifier Source: org_study_id

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