Apigenin in Increasing Health Benefits in High Risk Breast Clinic Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-15

Study Completion Date

2019-03-14

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Health Status Unknown

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Bio specimen Collection

Intervention Type PROCEDURE

Patients undergo collection of blood and urine

Dietary Intervention

Intervention Type DIETARY_SUPPLEMENT

Consume celery-banana bread

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Interventions

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Bio specimen Collection

Patients undergo collection of blood and urine

Intervention Type PROCEDURE

Dietary Intervention

Consume celery-banana bread

Intervention Type DIETARY_SUPPLEMENT

Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

Other Intervention Names

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Dietary Modification intervention, dietary Nutrition Intervention Nutrition Interventions Nutritional Interventions

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No