Apigenin in Increasing Health Benefits in High Risk Breast Clinic Patients

The Ohio State University

Status: Withdrawn

Conditions: Health Status Unknown

Treatments: Other: Laboratory Biomarker Analysis; Procedure: Bio specimen Collection; Dietary Supplement: Dietary Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03139227

NCI-2017-00517 (Registry Identifier)

OSU-17006

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Supportive Care (celery-banana bread)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Dietary Intervention

Procedure: Bio specimen Collection

Other: Laboratory Biomarker Analysis