Early Phase 1
Completed N=49
Broccoli Sprout/Broccoli Seed Extract Supplement in Decreasing Toxicity in Heavy Smokers
Cigarette Smoking-Related Carcinoma · Tobacco-Related Carcinoma
Source: ClinicalTrials.gov NCT03402230 ↗
Enrolled (actual)
49
Serious AEs
1.0%
Results posted
Apr 2021
Primary outcomePrimary: Change in Urinary Excretion of the Mercapturic Acid of Benzene Following 4 Tablets Per Day of Avmacol — 1.16 data presented as ratio; no unit
Summary
This randomized early phase I trial studies how well broccoli sprout/broccoli seed extract supplement works in decreasing toxicity in heavy smokers. Broccoli sprout/broccoli seed extract supplement is a dietary supplement made from broccoli sprout and seed extract powder, and may break down some of the cancer causing substances in tobacco smoke and produce substances that may protect cells from tobacco smoke-induced damage in current smokers.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Urinary Excretion of the Mercapturic Acid of Benzene Following 4 Tablets Per Day of Avmacol |
1.16 | — |
| PRIMARY Change in Urinary Excretion of the Mercapturic Acid of Benzene Following 8 Tablets Per Day of Avmacol |
1.19 | — |
| SECONDARY Change in the Urinary Excretion of the Mercapturic Acids of Acrolein and Crotonaldehyde |
1.11; 1.28; 1.05; 1.18 | — |
| SECONDARY Change in the NRF2 Target Gene Transcripts |
1.00 | — |
| SECONDARY Dose-response Relationship Between Avmacol Dose and Detoxification of Tobacco Carcinogens |
1.01; 1.14; 1.12 | — |
| SECONDARY Systemic Study Agent Exposure |
467.9; 990.0 | — |
Eligibility Criteria
Inclusion Criteria
- Current tobacco smokers with >= 20 pack years of self-reported smoking exposure and a current average use of >= 10 cigarettes/day
- Karnofsky performance scale >= 70%
- Leukocytes >= 3,000/microliter
- Absolute neutrophil count >= 1,500/microliter
- Platelets >= 100,000/microliter
- Total bilirubin = 5 mg daily for continued use > 14 days; use of inhaled steroids, nasal sprays, and topical creams for small body areas is allowed
- Participants may not be receiving any other investigational agents
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Avmacol
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant or lactating women
Data sourced from ClinicalTrials.gov (NCT03402230). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.