Apigenin in Increasing Health Benefits in High Risk Breast Clinic Patients

NCT03139227 | Withdrawn DMC

• 2 other identifiers: OSU-17006NCI-2017-00517
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Health Status Unknown

Outcome Measures

Primary Outcomes (1)

• Apigenin levels in blood and urine

  Paired t-tests will be used to compare mean apigenin levels.

  Up to 14 days

Study Arms (1)

Supportive Care (celery-banana bread)

EXPERIMENTAL

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.

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

Interventions

Bio specimen Collection PROCEDURE

Patients undergo collection of blood and urine

Supportive Care (celery-banana bread)

Dietary Intervention DIETARY_SUPPLEMENT

Consume celery-banana bread

Also known as: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions

Supportive Care (celery-banana bread)

Laboratory Biomarker Analysis OTHER

Correlative studies

Supportive Care (celery-banana bread)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Related Links

• The Jamesline

MeSH Terms

Interventions

Diet Therapy

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Sagar Sardesai, MBBS

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 17, 2017
• First Posted: May 3, 2017
• Study Start: August 15, 2017
• Primary Completion: March 14, 2019
• Study Completion: March 14, 2019
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share