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Broccoli Sprout Extracts in Healthy Volunteers: A Pilot Study of Nrf2 Pathway Modulation in Oral Mucosa (BSE)

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Julie E. Bauman, MD, MPH, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT02023931
First received: December 24, 2013
Last updated: January 14, 2016
Last verified: October 2014
  Purpose

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 Intervention Phase
Healthy Subject
Drug: Broccoli Sprout Extract (BSE)
Early Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Broccoli Sprout Extracts in Healthy Volunteers: A Pilot Study of Nrf2 Pathway Modulation in Oral Mucosa

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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


Enrollment: 10
Study Start Date: March 2014
Study Completion Date: January 2015
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
  1. The first regimen will involve oral delivery and ingestion of 600 μmole doses of glucoraphanin-rich BSE (GRR-BSE), and will represent systemic delivery of sulforaphane to oral mucosa, due to the necessity to metabolize GRR-BSE in the gut.
  2. The second regimen will involve oral delivery and ingestion of 100 μmole doses of sulforaphane-rich BSE (SFR-BSE), which will represent a combination of systemic and topical delivery to the oral mucosa.
  3. The third regimen will isolate topical exposure of the oral mucosa to sulforaphane. Participants will swish, hold, then spit 100 μmole doses of SFR-BSE. This regimen (SFR-BSE(T)) will theoretically isolate the pharmacodynamic impact of topical exposure of the oral mucosa to sulforaphane.
Other Names:
  • Glucoraphanin-rich BSE (GRR-BSE)
  • Sulforaphane-rich BSE (SFR-BSE)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years. Children will not be recruited into this study because children do not develop head and neck cancer.
  2. Both males and females are eligible.
  3. Members of all racial and ethnic groups are eligible.
  4. Smoking and non-smoking people are eligible. The tobacco use assessment form must be completed following consent and registration (Appendix B).
  5. 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
  6. No use of chronic prescribed medications which are potent inducers or inhibitors of CYP3A4 (Appendix A)
  7. No chronic anticoagulation
  8. No chronic use of steroids
  9. Karnofsky Performance Scale ≥90% (Appendix C)
  10. Able to provide written, informed consent
  11. For women of child-bearing potential (WOCBP), a negative urine pregnancy test must be documented within 7 days prior to the first study intervention
  12. No history of food intolerance to broccoli or pineapple and lime juices
  13. Willing to avoid cruciferous vegetables during the study interventions (Appendix D)
  14. Willing to avoid grapefruit or grapefruit juice 48 hours prior to or during the study
  15. Willing to avoid daily vitamins and anti-inflammatory medications prior to and during the study
  16. 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

Exclusion Criteria:

Failure to meet the above criteria

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02023931

Locations
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
Sponsors and Collaborators
Julie E. Bauman, MD, MPH
National Cancer Institute (NCI)
Investigators
Principal Investigator: Julie E Bauman, MD University ofPittsburgh
  More Information

Responsible Party: Julie E. Bauman, MD, MPH, Assistant Professor of Medicine,Director of the Section of Head and Neck Cancer, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02023931     History of Changes
Other Study ID Numbers: 13-079
5P50CA097190-09 ( US NIH Grant/Contract Award Number )
Study First Received: December 24, 2013
Last Updated: January 14, 2016

Keywords provided by University of Pittsburgh:
Oral mucosa
Nrf2 pathway
Broccoli Sprout Extract
Head and Neck Cancer

Additional relevant MeSH terms:
Sulforafan
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 24, 2017