Apigenin in Increasing Health Benefits in High Risk Breast Clinic Patients

Health Status Unknown Clinical Trial

Official title:

Celery-Based Dietary Intervention: A Feasibility Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03139227
• Other study ID #: OSU-17006
• Secondary ID: NCI-2017-00517
• Status: Withdrawn
• Phase: N/A
• Start date: August 15, 2017
• Est. completion date: March 14, 2019

Study information

• Verified date: September 2023
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 14, 2019
• Est. primary completion date: March 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Health Status Unknown

Intervention

Procedure:
• Bio specimen Collection
Patients undergo collection of blood and urine

Dietary Supplement:
• Dietary Intervention
Consume celery-banana bread

Other:
• Laboratory Biomarker Analysis
Correlative studies

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apigenin levels in blood and urine	Paired t-tests will be used to compare mean apigenin levels.	Up to 14 days

External Links

•   The Jamesline