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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03139227.
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.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationOhio State University Comprehensive Cancer Center
Principal InvestigatorSagar D. Sardesai
