Tier 1 — highest

Randomized Phase II Clinical Trial of Sulforaphane in Former Smokers at High Risk for Lung Cancer

Jian-Min Yuan, Thomas W Kensler, Sanja Dacic, Douglas J Hartman, Renwei Wang, Paula A Balogh, Pamela Sufka, Melissa A Turner, Kimberly Fuhrer, Lindsey Seigh, Yen Thi-Hai Pham, Jennifer Adams-Haduch, Giuseppe Valacchi, Shivendra V Singh, James G Herman, David O Wilson
Cancer Prevention Research 2025 18(6):335-345

Bibliography

PubMed
PMID 40041932
PubMed Central
PMC13321263
DOI
10.1158/1940-6207.CAPR-24-0386
Trial registry
View on ClinicalTrials.gov Registered trial — results not yet published in a peer-reviewed journal.
Funding
Supported by the National Cancer Institute, NIH, award R01CA213123. Nutramax Laboratories Consumer Care manufactured and provided Avmacol and placebo tablets for the study.
Competing interests
Jian-Min Yuan reported NIH grants during the study; Thomas W. Kensler reported the study grant plus an NIH/NCI grant outside the submitted work; Sanja Dacic reported personal fees from AstraZeneca and Roche outside the work. No disclosures were reported by the other authors.

Study snapshot

DesignRandomized placebo-controlled Phase II clinical trial
ModelFormer smokers at high risk for lung cancer
Sample43 randomized; 37 completed
InterventionPotential daily dose of 95 µmol sulforaphane versus placebo.
Duration12 months
EndpointsBronchial histopathology; Ki-67 proliferation index; Caspase-3; TUNEL apoptosis index; Safety

What the study showed, in plain terms

This 12-month Phase II trial tested sulforaphane in former smokers at high risk for lung cancer using paired bronchial biopsies rather than relying only on blood or urine biomarkers.

Key findings

Sulforaphane did not significantly improve bronchial histopathology and did not change caspase-3 or TUNEL indices. It did significantly reduce the Ki-67 proliferation index relative to placebo, and higher sulforaphane bioavailability correlated with greater Ki-67 reduction. No severe adverse events were observed.

What this study can and cannot tell us

Only 37 participants completed the study, and the positive result was a surrogate proliferation biomarker rather than lung-cancer incidence. The null histopathology and apoptosis endpoints are equally important to report.

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Dr. Khaled Mahmoud, MBBChCritical Care Medicine, Longevity Science & Editorial Direction Dr. Amr Yasser, PhDCardiometabolic, Musculoskeletal, Gut & Bioavailability Dr. Abdulla Mostafa, PhDCellular Senescence, Neurological, Mitochondrial & Brain-Ageing Biology