# Randomized Clinical Trial of Lung Cancer Chemoprevention with Sulforaphane in Former Smokers

> **NIH NIH R01** · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · 2021 · $616,685

## Abstract

ABSTRACT
 Lung cancer is the leading cause of cancer death. Cigarette smoking is the most important causal
factor. The smoking cessation program and antismoking campaign over the past 50 years has reduced the
prevalence of cigarette smoking by two-thirds in the US. Currently there are more former smokers than current
smokers. However, former smokers remain at high risk of lung cancer even after quitting smoking for many
years. Majority new lung cancer cases occur among former smokers. Unfortunately preventive intervention for
lung cancer among former smokers is still lacking. This proposed proof-of-principal study is to evaluate the
chemopreventive potentials of sulforaphane, a natural product formed from glucoraphanin in certain
cruciferous vegetables, on reducing the cellular and molecular risk biomarkers of lung cancer pathogenesis.
 Sulforaphane and other isothiocyanates derived from cruciferous vegetables have shown promising
chemopreventive properties in preclinical animal experiments, and in epidemiological studies and short-term
randomized clinical trials in humans. Dietary intake of sulforaphane significantly reduced the incidence of
tobacco-carcinogen induced lung adenocarcinoma in animal models that mimicked the scenario as former
smokers, along with the concurrent reduction of cell proliferation marker Ki-67 and the increase of apoptosis
markers caspase-3 and TUNEL. In short-term clinical trials in humans, intake of sulforaphane enhanced the
detoxification of environmental carcinogens and reduced Ki-67 index. Epidemiological studies demonstrated that
high intake of cruciferous vegetables or isothiocyanates was associated signficantly with reduced risk of lung
cancer in humans. However, clinical trials with a relatively long-term treatment of sulforaphane on the modulation of
lung cancer pathogenesis biomarkers are lacking.
 This proposed randomized, double-blinded, placebo-controlled, phase 2 clinical trial will enroll 72 former
smokers at high risk for lung cancer. All subjects will be randomly assigned to either treatment (daily minimal
dose of 120 µmol sulforaphane for 12 months) or placebo. Bronchoscopy-guided bronchial biopsy and
brushing, bronchoalveolar lavage, and nasal brushing, blood and urine samples will be collected pre- and post-
intervention. The specific aims are (1) to determine if sulforphane modulates the changes of bronchial
dysplasia index, cell proliferation marker Ki-67, and apoptosis markers caspase-3 and TUNEL in bronchial
biopsies, all of which have shown to be directly associated with lung cancer pathogenesis; and (2) to determine
if sulforaphane modulate the changes of the gene expression markers in bronchial and nasal epithelia that
have been shown to be directly linked to the development of lung cancer. The findings of the proposed study
will have significant public health implication in reducing lung cancer incidence and mortality in former
smokers. The ultimate goal is to develop, evaluate, and validate...

## Key facts

- **NIH application ID:** 10173712
- **Project number:** 5R01CA213123-05
- **Recipient organization:** UNIVERSITY OF PITTSBURGH AT PITTSBURGH
- **Principal Investigator:** Jian-Min Yuan
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $616,685
- **Award type:** 5
- **Project period:** 2017-06-14 → 2023-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10173712

## Citation

> US National Institutes of Health, RePORTER application 10173712, Randomized Clinical Trial of Lung Cancer Chemoprevention with Sulforaphane in Former Smokers (5R01CA213123-05). Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/grant/nih/10173712. Licensed CC0.

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