1. Effects of a green tea extract, Polyphenon E, on systemic biomarkers of growth factor signalling in women with hormone receptor-negative breast cancer.
- Author
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Crew, K. D., Ho, K. A., Brown, P., Greenlee, H., Bevers, T. B., Arun, B., Sneige, N., Hudis, C., McArthur, H. L., Chang, J., Rimawi, M., Cornelison, T. L., Cardelli, J., Santella, R. M., Wang, A., Lippman, S. M., and Hershman, D. L.
- Subjects
BREAST tumor treatment ,ANALYSIS of variance ,CHOLESTEROL ,CLINICAL trials ,DIETARY supplements ,ENZYME-linked immunosorbent assay ,GROWTH factors ,HIGH performance liquid chromatography ,LONGITUDINAL method ,MEDICAL cooperation ,ORAL drug administration ,POLYPHENOLS ,PROBABILITY theory ,REGRESSION analysis ,RESEARCH ,RESEARCH funding ,STATISTICAL sampling ,STATISTICAL hypothesis testing ,T-test (Statistics) ,WOMEN'S health ,GREEN tea ,PLANT extracts ,STATISTICAL significance ,OXIDATIVE stress ,VASCULAR endothelial growth factors ,BODY mass index ,RANDOMIZED controlled trials ,PRE-tests & post-tests ,REPEATED measures design ,BLIND experiment ,DATA analysis software ,DESCRIPTIVE statistics - Abstract
Background Observational and experimental data support a potential breast cancer chemopreventive effect of green tea. Methods We conducted an ancillary study using archived blood/urine from a phase IB randomised, placebo-controlled dose escalation trial of an oral green tea extract, Polyphenon E (Poly E), in breast cancer patients. Using an adaptive trial design, women with stage I- III breast cancer who completed adjuvant treatment were randomised to Poly E 400 mg ( n = 16), 600 mg ( n = 11) and 800 mg ( n = 3) twice daily or matching placebo ( n = 10) for 6 months. Blood and urine collection occurred at baseline, and at 2, 4 and 6 months. Biological endpoints included growth factor [serum hepatocyte growth factor ( HGF), vascular endothelial growth factor ( VEGF)], lipid (serum cholesterol, triglycerides), oxidative damage and inflammatory biomarkers. Results From July 2007-August 2009, 40 women were enrolled and 34 (26 Poly E, eight placebo) were evaluable for biomarker endpoints. At 2 months, the Poly E group (all dose levels combined) compared to placebo had a significant decrease in mean serum HGF levels (−12.7% versus +6.3%, P = 0.04). This trend persisted at 4 and 6 months but was no longer statistically significant. For the Poly E group, serum VEGF decreased by 11.5% at 2 months ( P = 0.02) and 13.9% at 4 months ( P = 0.05) but did not differ compared to placebo. At 2 months, there was a trend toward a decrease in serum cholesterol with Poly E ( P = 0.08). No significant differences were observed for other biomarkers. Conclusions Our findings suggest potential mechanistic actions of tea polyphenols in growth factor signalling, angiogenesis and lipid metabolism. [ABSTRACT FROM AUTHOR]
- Published
- 2015
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