Health Status UnknownNCT03139227
Apigenin in Increasing Health Benefits in High Risk Breast Clinic Patients
A study testing Bio specimen Collection, Dietary Intervention and Laboratory Biomarker Analysis in people with Health Status Unknown, run by Ohio State University Comprehensive Cancer Center.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Health Status Unknown
- What is being tested?
- Bio specimen Collection, Dietary Intervention and Laboratory Biomarker Analysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2017to 14 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Health Status Unknown
- Being tested
- Bio specimen Collection, Dietary Intervention, Laboratory Biomarker Analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bio specimen CollectionProcedure or surgery
Patients undergo collection of blood and urine
Dietary InterventionDietary supplement
Also called Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions
Consume celery-banana bread
Laboratory Biomarker AnalysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Bio specimen Collection; Dietary Supplement: Dietary Intervention; Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apigenin levels in blood and urine
Paired t-tests will be used to compare mean apigenin levels.
Measured: Up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start15 Aug 2017
- Primary completion14 Mar 2019
- Study completion14 Mar 2019
Why it stopped: PI decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Status UnknownStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sagar Sardesai, Ohio State University Comprehensive Cancer Center
- Investigators
- Sagar Sardesai, MBBS, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03139227
- Sponsor's protocol ID
- OSU-17006
- Other IDs
- NCI-2017-00517
- Status last verified
- Sep 2023
- First submitted
- 17 Apr 2017
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Celery-Based Dietary Intervention: A Feasibility Study
- ClinicalTrials.gov ID
- NCT03139227
- Acronym / sponsor ID
- OSU-17006
- Conditions
- Health Status Unknown
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 14 Mar 2019 (actual)
- Study completion
- 14 Mar 2019 (actual)
- First posted
- 3 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Care (celery-banana bread) | Experimental | Procedure: Bio specimen Collection, Dietary Supplement: Dietary Intervention, Other: Laboratory Biomarker AnalysisPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bio specimen CollectionPatients undergo collection of blood and urine | Procedure or surgery | Supportive Care (celery-banana bread) |
| Dietary InterventionAlso: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition InterventionsConsume celery-banana bread | Dietary supplement | Supportive Care (celery-banana bread) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Supportive Care (celery-banana bread) |
Primary outcome
Apigenin levels in blood and urine
Time frame: Up to 14 days
Paired t-tests will be used to compare mean apigenin levels.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sagar Sardesai, MBBS principal investigator
Ohio State University Comprehensive Cancer Center
Questions about this trial
What is this clinical trial studying?
A study testing Bio specimen Collection, Dietary Intervention and Laboratory Biomarker Analysis in people with Health Status Unknown, run by Ohio State University Comprehensive Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apigenin levels in blood and urine (time frame: Up to 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.