Broccoli Sprout Extracts in Healthy Volunteers: A Pilot Study of Nrf2 Pathway Modulation in Oral Mucosa (BSE)
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|ClinicalTrials.gov Identifier: NCT02023931|
Recruitment Status : Completed
First Posted : December 30, 2013
Last Update Posted : November 13, 2017
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A pilot study has been designed to determine (primary objective) if three brief interventions with three oral BSE regimens will alter mRNA biomarkers of Nrf2 pathway signaling, including NQO1, GSTs and AKRs, in the oral mucosa of healthy subjects. Quantitative distribution data and preliminary effect size for specific Nrf2 targets, as measured in serial buccal cell scrapings, will be determined during the course of 3-day exposures to three BSE regimens. These data will inform the design of a randomized, phase II chemoprevention trial in patients with HPV-negative HNSCC.
Ten healthy volunteers will be recruited for this pilot study, Age ≥ 18 years, both male and female: 1) The non-cancer population presenting to the University of Pittsburgh Eye and Ear Institute or the Hillman Cancer Center. This may include patients with benign disease or their friends/family members, or friends/family members of patients with cancer; 2) Professionals, staff, or students at the University of Pittsburgh.
|Condition or disease||Intervention/treatment||Phase|
|Healthy Subject||Drug: Broccoli Sprout Extract (BSE)||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Broccoli Sprout Extracts in Healthy Volunteers: A Pilot Study of Nrf2 Pathway Modulation in Oral Mucosa|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||January 2015|
Experimental: Broccoli Sprout Extract Drink
Three different regimens of BSE delivery will be evaluated in each participant, with participants serving as their own controls. Each regimen will involve a 3 day exposure, with daily collection of buccal cell scrapings. Between regimens, a minimum 3 day (72 hour) washout period will occur.
Drug: Broccoli Sprout Extract (BSE)
- Determine the modulation of the Nrf2 pathway in response to short term exposure to three BSE regimens [ Time Frame: Three to 11 weeks ]
The primary objective is limited to obtaining preliminary estimates of Nrf2 pathway modulation from buccal cell specimens samples all collected during each of the three 5 day intervention periods. Endpoints include mRNA transcript levels of certain genes or enzymes regulated by Nrf2.
Note that the goals of this study are limited to obtaining initial pharmacodynamic estimates of Nrf2 pathway modulation for each BSE intervention. Accordingly, no hypothesis testing or comparative analyses are planned. The data collected in this pilot study may be used to plan a future definitive prevention trial.
- Estimate modulation of Nrf2 pathway markers in PBMCs and metabolites of SFN in urine [ Time Frame: Three to 11 weeks ]Individual subjects profile plots will be constructed for each endpoint as measured at various times over days 1-5 of each regimen will be plotted. An omnibus test of change over time such as the Friedman test of Mack-Skillings test will be conducted to verify general endpoint modulation. Regimen-specific profiles will be estimated with mixed linear or generalized mixed linear models
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- Age ≥ 18 years. Children will not be recruited into this study because children do not develop head and neck cancer.
- Both males and females are eligible.
- Members of all racial and ethnic groups are eligible.
- Smoking and non-smoking people are eligible. The tobacco use assessment form must be completed following consent and registration (Appendix B).
- No current or former diagnosis of cancer, with the exception of: excised and cured non-melanoma skin cancer; or carcinoma in situ of the cervix
- No use of chronic prescribed medications which are potent inducers or inhibitors of CYP3A4 (Appendix A)
- No chronic anticoagulation
- No chronic use of steroids
- Karnofsky Performance Scale ≥90% (Appendix C)
- Able to provide written, informed consent
- For women of child-bearing potential (WOCBP), a negative urine pregnancy test must be documented within 7 days prior to the first study intervention
- No history of food intolerance to broccoli or pineapple and lime juices
- Willing to avoid cruciferous vegetables during the study interventions (Appendix D)
- Willing to avoid grapefruit or grapefruit juice 48 hours prior to or during the study
- Willing to avoid daily vitamins and anti-inflammatory medications prior to and during the study
- Potential effects of Broccoli sprout extract on the developing human fetus: The effects of Broccoli Sprout Extract on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and for the duration of study participation
Failure to meet the above criteria
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): NCT02023931
|United States, Pennsylvania|
|Eye and Ear Institute|
|Pittsburgh, Pennsylvania, United States, 15213|
|UPMC Hillman Cancer Center (University of Pittsburgh Cancer Institute)|
|Pittsburgh, Pennsylvania, United States, 15232|
|Principal Investigator:||Julie E Bauman, MD||University ofPittsburgh|
|Responsible Party:||Julie E. Bauman, MD, MPH, Assistant Professor of Medicine,Director of the Section of Head and Neck Cancer, University of Pittsburgh|
|Other Study ID Numbers:||
5P50CA097190-09 ( U.S. NIH Grant/Contract )
|First Posted:||December 30, 2013 Key Record Dates|
|Last Update Posted:||November 13, 2017|
|Last Verified:||November 2017|
Broccoli Sprout Extract
Head and Neck Cancer
Physiological Effects of Drugs