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NCT Number: NCT06926530

Herbs & Supplements in Breast Cancer Usage, Impact, and Personalized Approaches for Diverse Populations

This research study is enrolling participants diagnosed with breast cancer and receiving/received chemotherapy and/or endocrine therapy. The study's primary objective is to assess the differences in the use of herbs and supplements among the populations served at Cleveland Clinic Florida and Ohio by administering a participant-reported questionnaire.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic Florida, Weston, Florida, United States

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About this study

The world has seen a rise in the use of Complementary and Alternative Medicine (CAM) since the early 1980s. This interest in CAM was significant in the United States to the extent that Congress established and set the Dietary Supplement Health and Education Act of 1994 to define what a dietary supplement entails and to launch a legal framework that oversees these products. In 2020, the National Health and Nutrition Examination survey found that the prevalence of dietary supplements among adults was around 58.5%, with sales reaching $55.7 Billion. Notably, the consumption of dietary supplements is not limited to healthy individuals. Individuals with cancer are significant consumers of such products, with a prevalence rate as high as 50% in the United States. CAM use originates from traditional and cultural practices outside of the Western healthcare system. The literature on the association between CAM use and ethnicity presents conflicting data. Most of the available studies are old, dating to the early 2000s, and lack proper ethnic representation. Additionally, there is a notable gap in the literature regarding the utilization of CAM in breast cancer patients within ethnic minorities. This study aims to evaluate ethnicity and its influence on the use of herbs and supplements in early-stage breast cancer (Stages 1,2,3) in two populations: participants receiving care at Cleveland Clinic Florida and those receiving care at Cleveland Clinic Ohio. The investigators also aim to evaluate the interactions between the most used herbs and supplements with standard therapy, be it endocrine therapy or chemotherapy. The investigators will select the top 10 by frequency of the used herbs and supplements and cross-match it with the Memorial Sloan Kettering Cancer Center integrative medicine "Search about Herbs" (https://www.mskcc.org/cancer-care/diagnosis-treatment/symptom-management/integrative-medicine/herbs/search) as well as "Herbs at glance" via the NIH website (https://www.nccih.nih.gov/health/herbsataglance). Moreover, the investigators aim to determine the prevalence of herbs and supplements use in individuals with breast cancer.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 18 years and older.
  • Breast cancer diagnosis at pathologic stage (I, II, and III)
  • Participants with regional lymph node involvement
  • Received Chemotherapy and/ or Endocrine therapy
  • Established patients followed by a medical oncologist at Cleveland Clinic Florida and Ohio
  • Able and willing to participate in the one-time survey.

Exclusion criteria

  • Under 18 years of age
  • Prior history of cancer diagnosis
  • Unable or unwilling to participate in the survey
  • Distant Metastatic Disease

Treatment and study plan

No intervention

Other

Participants will complete a one-time 33-question survey. The survey is comprised of three sections: (1) Section A includes 12 questions related to demographic information, (2) Section B consists of 2 questions addressing treatment characteristics, & (3) Section C contains 19 questions focusing on supplement usage.

Primary outcomes

  1. Influence of ethnicity on herb/supplement usage among early stage breast cancer participants.

    Time frame: 5 months

    Univariate analysis in which Chi-square test or Fisher's exact test will be performed.

Secondary outcomes

  1. Determine the ten most common herbs and supplements by frequency of use in each Cancer Center.

    Time frame: 5 months

  2. Determine the Prevalence of Herbs and Supplements in breast cancer patients.

    Time frame: 5 months

  3. Assess potential associations between Conventional treatments and Herbs/Supplements.

    Time frame: 5 months

    Measured by multiple logistic regression model

  4. Association between cancer stage and herbs/supplement usage.

    Time frame: 5 months

    Measured by multiple logistic regression model

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth Stone, MD

CONTACT

[email protected]

954-659-5840

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Registry information

Official study title

Navigating Herbs and Supplements in Breast Cancer: Usage, Impact, and Personalized Approaches for Diverse Populations

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 13, 2025
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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