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

April 27, 2026 updated by: Case Comprehensive Cancer Center

Navigating Herbs and 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Elizabeth Stone, MD
  • Phone Number: 954-659-5840
  • Email: stonee@ccf.org

Study Locations

  • United States
    • Florida
      • Weston, Florida, United States, 33331
        • Cleveland Clinic Florida
        • Contact:
          • Elizabeth Stone, MD
          • Phone Number: 954-659-5840
          • Email: stonee@ccf.org
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Main Campus
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Established stages I, II, and III breast cancer patients at Cleveland Clinic Florida and Ohio who received care will be screened by the research fellow before or after their oncology visit.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the ten most common herbs and supplements by frequency of use in each Cancer Center.
Time Frame: 5 months
5 months
Determine the Prevalence of Herbs and Supplements in breast cancer patients.
Time Frame: 5 months
5 months
Assess potential associations between Conventional treatments and Herbs/Supplements.
Time Frame: 5 months
Measured by multiple logistic regression model
5 months
Association between cancer stage and herbs/supplement usage.
Time Frame: 5 months
Measured by multiple logistic regression model
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Case Comprehensive Cancer Center

Investigators

  • Principal Investigator: Elizabeth Stone, MD, Case Comprehensive Cancer Center, Cleveland Clinic Florida

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 Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

April 7, 2025

First Submitted That Met QC Criteria

April 11, 2025

First Posted (Actual)

April 13, 2025

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CASE8124

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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