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.

Study Overview

• Status: Withdrawn
• Conditions: Health Status Unknown
• Intervention / Treatment: Other: Laboratory Biomarker Analysis; Procedure: Bio specimen Collection; Dietary supplement: Dietary Intervention

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 Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Supportive Care (celery-banana bread); 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.

Other: Laboratory Biomarker Analysis; Correlative studies; Procedure: Bio specimen Collection; Patients undergo collection of blood and urine; Dietary supplement: Dietary Intervention; Consume celery-banana bread; Other Names: Dietary Modification; intervention, dietary; Nutrition Intervention; Nutrition Interventions; Nutritional Interventions

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Investigators: Principal Investigator: Sagar Sardesai, MBBS, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2017
• Primary Completion (Actual): March 14, 2019
• Study Completion (Actual): March 14, 2019

Study Registration Dates

• First Submitted: April 17, 2017
• First Submitted That Met QC Criteria: May 2, 2017
• First Posted (Actual): May 3, 2017

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 9, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: OSU-17006; NCI-2017-00517 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No