RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-07-01
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04650256

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Female subjects with newly diagnosed breast carcinoma
  2. * \> 18 years of age
  3. * Post-mastectomy with or without reconstruction
  4. * Stage II-IIIb with any receptor status
  5. * All races and ethnicities are eligible
  6. * Patients must be able to consent in English or Spanish
  7. * Plan to receive adjuvant radiotherapy to the chest wall +/- regional lymph nodes
  8. * RT will involve standard fractionation use of 3D conformal or Intensity-modulated RT (IMRT)
  9. * Willing to sign protocol consent form
  10. * Patients are allowed to receive adjuvant hormonal therapy and/or targeted therapies such as trastuzumab prior to, during and/or after radiation therapy.
  11. * Patients may receive chemotherapy before or after radiation therapy
  1. * Prior radiation to the involved breast or chest wall
  2. * Concurrent chemotherapy
  3. * Unable or unwilling to sign informed consent
  4. * Unable to speak English or Spanish
  5. * Pregnant women
  6. * Clinical or pathologic stage T4
  7. * Metastatic disease
  8. * Connective tissue disorder including Systemic Lupus Erythematosus and Scleroderma

Contacts and Locations

Study Contact

Jennifer J Hu, PhD
CONTACT
3052437796
jhu@med.miami.edu

Principal Investigator

Jennifer J Hu, PhD
PRINCIPAL_INVESTIGATOR
U. of Miami

Study Locations (Sites)

University of Miami
Miami, Florida, 33136
United States

Collaborators and Investigators

Sponsor: University of Miami

  • Jennifer J Hu, PhD, PRINCIPAL_INVESTIGATOR, U. of Miami

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-07-01
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2021-07-01
Study Completion Date2024-12-31

Terms related to this study

Keywords Provided by Researchers

  • Breast cancer
  • Radiotherapy
  • Complementary and alternative medicine

Additional Relevant MeSH Terms

  • Skin Toxicity