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

Completed · Early Phase 1

Conditions studied: Healthy Subject

In brief

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.

Key facts

Study ID: NCT02023931
Run by: Julie E. Bauman, MD, MPH
People needed: 10
Starts: 2014-03-01
Expected to finish: 2015-01-01
Last updated by the study team: 2017-11-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

Failure to meet the above criteria

Where it is running

Eye and Ear Institute — Pittsburgh, Pennsylvania, United States
UPMC Hillman Cancer Center (University of Pittsburgh Cancer Institute) — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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