Apigenin in Increasing Health Benefits in High Risk Breast Clinic Patients

Not Applicable

Withdrawn

• Conditions: Health Status Unknown
• Interventions: Procedure: Bio specimen Collection; Dietary Supplement: Dietary Intervention; Other: Laboratory Biomarker Analysis

• Registration Number: NCT03139227
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-04-17
• Study First Submitted QC: 2017-05-02
• Study First Posted: 2017-05-03
• Study Start: 2017-08-15
• Primary Completion: 2019-03-14
• Study Completion: 2019-03-14
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-09
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive Care (celery-banana bread)	Bio specimen Collection	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.
Supportive Care (celery-banana bread)	Dietary Intervention	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.
Supportive Care (celery-banana bread)	Laboratory Biomarker Analysis	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.

Primary Outcome Measures

Name	Time	Method
Apigenin levels in blood and urine	Up to 14 days	Paired t-tests will be used to compare mean apigenin levels.