Apigenin in Increasing Health Benefits in High Risk Breast Clinic Patients

Celery-Based Dietary Intervention: A Feasibility Study

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.

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.

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