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Randomized phase II clinical trial of sulforaphane in former smokers at high risk for lung cancer

莱菔硫烷 随机对照试验 肺癌 医学 癌症 临床试验 十字花科蔬菜 内科学 癌症预防 肿瘤科 癌症研究
作者
Jian‐Min Yuan,Thomas W. Kensler,Sanja Đačić,Douglas J. Hartman,Renwei Wang,Paula 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
出处
期刊:Cancer Prevention Research [American Association for Cancer Research]
标识
DOI:10.1158/1940-6207.capr-24-0386
摘要

Experimental studies have shown dietary isothiocyanates reduced cellular proliferative marker Ki-67 and increased apoptotic markers Caspase-3 and TUNEL in animals, but human data are lacking. The present study was to assess whether sulforaphane would stop/reverse the progression of bronchial histopathology, reduce Ki-67 index and/or increase Caspase-3 and TUNEL indices in humans. A randomized clinical trial (NCT03232138) was conducted in former smokers. Forty-three subjects were randomly assigned to the placebo or the treatment with a potential daily dose of 95 µmol sulforaphane for 12 months. The endpoints were the changes of histopathology scores, and Ki-67, Caspase-3 and TUNEL indices in post- vs. pre-treatment bronchial biopsies. Thirty-seven participants (17 in the sulforaphane and 20 in the placebo group) completed the study. Supplementation of sulforaphane did not show significant impact on bronchial histopathology, but significantly reduced Ki-67 index with a 20% decrease in the sulforaphane group and a 65% increase in the placebo (p = 0.014). The difference was even greater in high-density (3+) positive Ki-67, with a 44% decrease in the sulforaphane group compared with a 71% increase in the placebo (p = 0.004). Higher bioavailability of sulforaphane was correlated with greater reduction of Ki-67 index (P for trend = 0.019). Sulforaphane treatment had no impact on Caspase-3 or TUNEL index in bronchial biopsies. No severe adverse event was observed in the study participants. The findings of oral sulforaphane that significantly reduced Ki-67 index in bronchial tissue support further development as a potential chemopreventive agent against lung cancer development.
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