Trials / Completed
CompletedNCT03182959
Broccoli Sprout Extract in Preventing Recurrence in Patients With Tobacco-Related Head and Neck Squamous Cell Cancer
A Phase 0 Study Evaluating the Systemic Bioavailability and Pharmacodynamic Effects of Avmacol® in the Oral Mucosa of Patients Following Curative Treatment for Tobacco-related Head and Neck Cancer
- Status
- Completed
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- University of Arizona · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is being done to see whether Avmacol®, a dietary supplement made from broccoli sprout and seed extract powder, induces changes in inner cheek cells that may be protective against environmental toxins such as tobacco. There are three main goals of the study: 1. To learn whether the dietary supplement, Avmacol®, can stimulate cheek cells to repair damage from environmental toxins; 2. to learn how the body metabolizes Avmacol®, by measuring its byproducts in the participant's urine and blood; 3. to learn whether the immune system can be stimulated by Avmacol®, by studying the natural killer cells and T cells in the participant's blood.
Detailed description
This study hypothesizes that nuclear factor erythroid 2-related factor 2 (NRF2) pathway activation in oral epithelium can be induced by administering Avmacol® to patients curatively treated for a first tobacco-related HNSCC. The aim of this Phase 0 clinical study is to determine the oral bioavailability of sulforaphane in the commercially available dietary supplement, Avmacol®, and to determine the level of pharmacodynamic upregulation of NRF2 target gene transcripts that occurs in the oral epithelium of patients who have completed curative treatment for tobacco-related HNSCC, including high grade dysplasia, carcinoma in situ, or invasive carcinoma.
Conditions
- HNSCC
- Head and Neck Cancer
- Head and Neck Squamous Cell Carcinoma
- Tobacco-Related Carcinoma
- Carcinoma in Situ
- Dysplasia
- Hyperplasia
- Premalignant Lesion
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Avmacol® | Avmacol® tablets |
Timeline
- Start date
- 2017-04-24
- Primary completion
- 2020-01-01
- Completion
- 2021-01-19
- First posted
- 2017-06-09
- Last updated
- 2021-06-21
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03182959. Inclusion in this directory is not an endorsement.