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

NCT ID: NCT06926530

Last Updated: 2025-07-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 240 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2026-04-30

Brief Summary

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.

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.

Conditions

Breast Cancer; Breast Cancer Stage I; Breast Cancer Stage II; Breast Cancer Stage III; Breast Carcinoma

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Interventions

No intervention

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elizabeth Stone, MD

Role: PRINCIPAL_INVESTIGATOR

Case Comprehensive Cancer Center, Cleveland Clinic Florida

Locations

Cleveland Clinic Florida

Weston, Florida, United States

Cleveland Clinic Main Campus

Cleveland, Ohio, United States

Countries

United States

Central Contacts

Elizabeth Stone, MD

Role: CONTACT

stonee@ccf.org

954-659-5840

Facility Contacts

Elizabeth Stone, MD

Role: primary

stonee@ccf.org

954-659-5840

Erin Roesch, MD

Role: primary

roesche2@ccf.org

216-444-9772

Other Identifiers

CASE8124

Identifier Type: -

Identifier Source: org_study_id