Apigenin in Increasing Health Benefits in High Risk Breast Clinic Patients

Study Overview
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Brief Summary
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This pilot clinical trial studies the side effects and best dose of apigenin in increasing health benefits in high risk breast clinic patients. Celery is high in apigenin, a compound that may have anti-cancer activities. Eating a celery-based diet may help in prevention and treatment of inflammatory diseases including cancer.

Detailed Description
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PRIMARY OBJECTIVES; I. To determine the feasibility of apigenin oral supplementation using a specially formulated celery-banana bread. II. To determine the safety and tolerability of apigenin supplementation. OUTLINE: This is a dose-escalation study. Patients consume one serving of lower dose apigenin celery-banana bread daily on days 1-7, and then consume one serving of higher dose apigenin celery-banana bread on days 8-14. Patients undergo blood sample collection on day 1 prior to and 6 hours after bread ingestion, on day 8 prior to and 6 hours after ingestion of bread, and on day 15 (or endpoint). Patients also provide a baseline urine sample and then 24-hour urine samples on days 1, 7, 8, and 14.

Official Title
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Celery-Based Dietary Intervention: A Feasibility Study

Conditions
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Health Status Unknown

Intervention / Treatment
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* Procedure: Bio specimen Collection
* Dietary Supplement: Dietary Intervention
* Other: Laboratory Biomarker Analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients should be followed in Stefanie Spielman Comprehensive Breast Center (SSCBC) High Risk Breast Clinic No known allergy to ingredients of banana bread preparation (eggs, almonds and other nuts since the celery also has almond powder) Must be > 1 year from pregnancy, lactation or chemotherapy Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Ability to give informed consent Participate in the specified study visits and laboratory testing including three (20 mL) blood draws and three 24 hour urine collections Exclusion Criteria: Concurrent malignancy or metastatic malignancy of any kind Ongoing chemotherapy, radiation therapy, or other cancer-related treatment Current and past history of hypertension Chronic use of any herbal or dietary supplement containing apigenin within the 3 months prior to entry on the study Pregnant or nursing women Concurrent use of tamoxifen, raloxifene, or any of the aromatase inhibitors

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive Care (celery-banana bread)<br>Patients consume one serving of lower dose apigenin celery-banana bread daily on days 1-7, and then consume one serving of higher dose apigenin celery-banana bread on days 8-14. Patients undergo blood sample collection on day 1 prior to and 6 hours after bread ingestion, on day 8 prior to and 6 hours after ingestion of bread, and on day 15 (or endpoint). Patients also provide a baseline urine sample and then 24-hour urine samples on days 1, 7, 8, and 14. | Procedure: Bio specimen Collection<br>* Patients undergo collection of blood and urine<br>Dietary Supplement: Dietary Intervention<br>* Consume celery-banana bread<br>* Other names: Nutritional Interventions;Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apigenin levels in blood and urine | Paired t-tests will be used to compare mean apigenin levels. | Up to 14 days |