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Apigenin in Increasing Health Benefits in High Risk Breast Clinic Patients

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ClinicalTrials.gov Identifier: NCT03139227
Recruitment Status : Withdrawn (PI decision)
First Posted : May 3, 2017
Last Update Posted : November 20, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Health Status Unknown Procedure: Bio specimen Collection Dietary Supplement: Dietary Intervention Other: Laboratory Biomarker Analysis Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Celery-Based Dietary Intervention: A Feasibility Study
Actual Study Start Date : August 15, 2017
Actual Primary Completion Date : March 14, 2019
Actual Study Completion Date : March 14, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Apigenin

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.
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

Other: Laboratory Biomarker Analysis
Correlative studies




Primary Outcome Measures :
  1. Apigenin levels in blood and urine [ Time Frame: Up to 14 days ]
    Paired t-tests will be used to compare mean apigenin levels.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03139227


Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
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Principal Investigator: Sagar Sardesai, MBBS Ohio State University Comprehensive Cancer Center
Additional Information:
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Responsible Party: Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03139227    
Other Study ID Numbers: OSU-17006
NCI-2017-00517 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: May 3, 2017    Key Record Dates
Last Update Posted: November 20, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No