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
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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RECRUITING
NA
40 participants
INTERVENTIONAL
2021-07-01
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* \> 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
* 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
18 Years
FEMALE
No
Sponsors
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VAUGHN-JORDAN FOUNDATION, INC.
UNKNOWN
Florida Breast Cancer Foundation
OTHER
University of Miami
OTHER
Responsible Party
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Jennifer Hu
Professor
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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20200491
Identifier Type: -
Identifier Source: org_study_id
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