Clinical trial · Interventional
Broccoli Sprout Extracts in Healthy Volunteers: A Pilot Study of Nrf2 Pathway Modulation in Oral Mucosa
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Healthy Subject | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Broccoli Sprout Extract (BSE) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Broccoli Sprout Extract Drink
- description
- 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.
- interventionNames
- Drug: Broccoli Sprout Extract (BSE)
Primary outcomes (1)
- measure
- Determine the modulation of the Nrf2 pathway in response to short term exposure to three BSE regimens
- timeFrame
- Three to 11 weeks
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
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