Clinical trial NCT06926530: Herbs & Supplements in Breast Cancer Usage, Impact, and Personalized Approaches for Diverse Populations
Official title: Navigating Herbs and Supplements in Breast Cancer: Usage, Impact, and Personalized Approaches for Diverse Populations
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
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
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2025-04-13
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.

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

Primary outcomes:
measure: Influence of ethnicity on herb/supplement usage among early stage breast cancer participants.
timeFrame: 5 months
Secondary outcomes:
measure: Determine the ten most common herbs and supplements by frequency of use in each Cancer Center.
timeFrame: 5 months
measure: Determine the Prevalence of Herbs and Supplements in breast cancer patients.
timeFrame: 5 months
measure: Assess potential associations between Conventional treatments and Herbs/Supplements.
timeFrame: 5 months
measure: Association between cancer stage and herbs/supplement usage.
timeFrame: 5 months
Other outcomes:
Locations:
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Cleveland
country: United States
facility: Cleveland Clinic Main Campus
state: Ohio
Study officials:
affiliation: Case Comprehensive Cancer Center, Cleveland Clinic Florida
name: Elizabeth Stone, MD
role: PRINCIPAL_INVESTIGATOR
References: