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

NCT06926530 | Not Yet Recruiting DMC

• 1 other identifier: CASE8124
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Complementary and Alternative Medicine; Alternative medicine; Herbs; Supplements; Complementary therapies; Holistic health

Outcome Measures

Primary Outcomes (1)

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

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

  5 months

Secondary Outcomes (4)

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

  5 months

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

  5 months

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

  5 months

• Association between cancer stage and herbs/supplement usage.

  5 months

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (2)

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

Cleveland Clinic Main Campus

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Elizabeth Stone, MD

  Case Comprehensive Cancer Center, Cleveland Clinic Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Stone, MD

CONTACT

954-659-5840; stonee@ccf.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 13, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)