Breast CancerNCT06926530
Herbs & Supplements in Breast Cancer Usage, Impact, and Personalized Approaches for Diverse Populations
An observational study of Breast Cancer and Breast Cancer Stage I, run by Case Comprehensive Cancer Center at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Breast Cancer Stage I, Breast Cancer Stage II
- How many people
- 240 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2026to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Under 18 years of age
- Prior history of cancer diagnosis
- Unable or unwilling to participate in the survey
- Distant Metastatic Disease
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Cleveland Clinic Main Campus
Cleveland, Ohio, 44195
Erin Roesch, MD, 216-444-9772, roesche2@ccf.org
Cleveland Clinic Florida
Weston, Florida, 33331
Elizabeth Stone, MD, 954-659-5840, stonee@ccf.org
About this study
Official title: 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.
Read the 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
- Being tested
- No intervention
- Keywords
- Complementary and Alternative Medicine, Alternative medicine, Herbs, Supplements, Complementary therapies, Holistic health
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 months
Secondary outcomes (4)
Determine the ten most common herbs and supplements by frequency of use in each Cancer Center.
Measured: 5 months
Determine the Prevalence of Herbs and Supplements in breast cancer patients.
Measured: 5 months
Assess potential associations between Conventional treatments and Herbs/Supplements.
Measured by multiple logistic regression model
Measured: 5 months
Association between cancer stage and herbs/supplement usage.
Measured by multiple logistic regression model
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study startOct 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth Stone, MD, Principal investigator, Case Comprehensive Cancer Center, Cleveland Clinic Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06926530
- Sponsor's protocol ID
- CASE8124
- Status last verified
- Aug 2026
- First submitted
- 7 Apr 2025
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Navigating Herbs and Supplements in Breast Cancer: Usage, Impact, and Personalized Approaches for Diverse Populations
- ClinicalTrials.gov ID
- NCT06926530
- Acronym / sponsor ID
- CASE8124
- 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
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 13 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Under 18 years of age
- Prior history of cancer diagnosis
- Unable or unwilling to participate in the survey
- Distant Metastatic Disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionParticipants 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. | Other | – |
Primary outcome
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.
4 secondary outcomes
Determine the ten most common herbs and supplements by frequency of use in each Cancer Center.
Time frame: 5 months
Determine the Prevalence of Herbs and Supplements in breast cancer patients.
Time frame: 5 months
Assess potential associations between Conventional treatments and Herbs/Supplements.
Time frame: 5 months
Association between cancer stage and herbs/supplement usage.
Time frame: 5 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elizabeth Stone, MD principal investigator
Case Comprehensive Cancer Center, Cleveland Clinic Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Breast Cancer Stage I, run by Case Comprehensive Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Stone, MD (954-659-5840, stonee@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Influence of ethnicity on herb/supplement usage among early stage breast cancer participants. (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.