Randomized Phase II Clinical Trial of Sulforaphane in Former Smokers at High Risk for Lung Cancer
Yuan JM, Kensler TW, Dacic S, Hartman DJ, Wang R, Balogh PA, Sufka P, Turner MA, Fuhrer K, Seigh L, Pham YT, Adams-Haduch J, Valacchi G, Valacchi G, Singh SV, Herman JG, Wilson DO
Cancer prevention research (Philadelphia, Pa.) · 11 citas
Etiquetas de revisión
Solo mecanismosDatos neutrales que nuestra revisión registró sobre cómo se hizo este estudio. Describen el método, nunca si nos gusta el resultado.
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Solo mecanismos
- Consumo medido con
- No se indica
Quién lo pagó
- Financiación
- Financiación independiente
- Gobierno
- Division of Cancer Prevention, National Cancer Institute
- Gobierno
- National Cancer Institute
- Gobierno
- NCI NIH HHS
- Gobierno
- Division of Cancer Prevention, National Cancer Institute (DCP, NCI)
- Subvenciones
- National Cancer Institute (P30 CA 047904); Division of Cancer Prevention, National Cancer Institute (R01CA213123); National Cancer Institute (T32CA186873); National Cancer Institute (R01CA213123)
Según 4 financiadores declarados.
Publicación
- Publicado
- 2025-03-05 · Cancer Prev Res (Phila) · vol. 18 · número 6 · págs. 335–345
- Editorial
- American Association for Cancer Research
- Citado
- 15 citas · más que el 95% de estudios similares · 3.8× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 54 trabajos
- Acceso
- De pago
- Áreas de investigación
- Genomics, phytochemicals, and oxidative stress · Lung Cancer Diagnosis and Treatment · Lung Cancer Research Studies
- Palabras clave
- sulforaphane, lung cancer chemoprevention, former smokers, Ki-67, caspase-3, TUNEL, isothiocyanates, oral supplementation, cruciferous vegetables
- MeSH
- bronchi, humans, lung neoplasms, isothiocyanates, sulfoxides, ki-67 antigen, anticarcinogenic agents, double-blind method, smoking, apoptosis, aged, middle aged, female, male, caspase 3, smokers
16 autores
- Jian‐Min Yuan🇺🇸University of Pittsburgh; UPMC Hillman Cancer Center; University of Pittsburgh Medical Center
- Thomas W. Kensler🇺🇸University of Pittsburgh; Fred Hutch Cancer Center
- Sanja Đačić🇺🇸University of Pittsburgh; Yale University
- Douglas J. Hartman🇺🇸University of Pittsburgh
- Renwei Wang🇺🇸UPMC Hillman Cancer Center; University of Pittsburgh Medical Center
- Paula A. Balogh🇺🇸University of Pittsburgh; UPMC Hillman Cancer Center; University of Pittsburgh Medical Center
- Pamela Sufka🇺🇸University of Pittsburgh; UPMC Hillman Cancer Center; University of Pittsburgh Medical Center
- Melissa A. Turner🇺🇸University of Pittsburgh; UPMC Hillman Cancer Center; University of Pittsburgh Medical Center
- Kimberly Fuhrer🇺🇸University of Pittsburgh
- Lindsey Seigh🇺🇸University of Pittsburgh
- Yen Thi‐Hai Pham🇺🇸UPMC Hillman Cancer Center; University of Pittsburgh Medical Center
- Jennifer M. Adams‐Haduch🇺🇸UPMC Hillman Cancer Center; University of Pittsburgh Medical Center
- Giuseppe Valacchi🇺🇸🇮🇹🇰🇷North Carolina State University; University of Ferrara; Kyung Hee University
- Shivendra Vikram Singh🇺🇸University of Pittsburgh; UPMC Hillman Cancer Center; University of Pittsburgh Medical Center
- James Gordon Herman🇺🇸University of Pittsburgh; UPMC Hillman Cancer Center; University of Pittsburgh Medical Center
- David O. Wilson🇺🇸University of Pittsburgh; UPMC Hillman Cancer Center; University of Pittsburgh Medical Center
Resumen
El texto original del estudio, en el idioma en que se publicó.
Experimental studies have shown that dietary isothiocyanates reduced cellular proliferative marker Ki-67 and increased apoptotic markers caspase-3 and terminal deoxynucleotidyl transferase-mediated dUTP nick end labeling (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 the 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 in histopathology scores and Ki-67, caspase-3, and TUNEL indices in post- versus pretreatment 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 the 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 the Ki-67 index (P for trend = 0.019). Sulforaphane treatment had no impact on the 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 the Ki-67 index in bronchial tissue support further development as a potential chemopreventive agent against lung cancer development. Prevention Relevance: High intake of cruciferous vegetables and their sulforaphane is associated with lower incidence of lung cancer in humans and animal models. This clinical trial has demonstrated that oral supplementation of sulforaphane for 12 months significantly reduced the Ki-67 index, a potential surrogate endpoint of biomarkers for lung cancer risk.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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