Apigenin in Increasing Health Benefits in High Risk Breast Clinic Patients
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/25/2017 |
| Start Date: | August 15, 2017 |
| End Date: | August 31, 2020 |
| Contact: | The Ohio State University Comprehensive Cancer Center |
| Email: | OSUCCCClinicaltrials@osumc.edu |
| Phone: | 1-800-292-5066 |
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.
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.
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.
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.
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
We found this trial at
1
site
Columbus, Ohio 43210
Principal Investigator: Sagar D. Sardesai, MBBS
Phone: 614-293-0066
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