***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
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    ***EXAMPLES*** 
    Input: Purpose Epidemiologic studies suggest that consumption of green tea may have a protective effect against the development of several cancers . Pre clinical studies of green tea and its polyphenolic components have demonstrated antimutagenic and anticarcinogenic activity , and inhibition of growth of tumor cell lines and animal tumor models , including lung cancer . Green tea may also have chemopreventive properties , and enhancement of cytotoxicity of chemotherapeutic agents has been demonstrated . This trial was design ed to determine the maximum tolerated dose ( MTD ) of green tea extract ( GTE ) in patients with advanced lung cancer . Methods A total of 17 patients with advanced lung cancer were registered to receive once-daily oral dosing of GTE at a starting dose of 0.5 g/m2 per day , with an accelerated dose-escalation scheme . Results On this schedule , the MTD of GTE was 3 g/m2 per day , and at this dose ,  GTE  was well tolerated with no grade 3 or 4 toxicity seen . Dose-limiting toxicities were diarrhea , nausea and hypertension . No objective responses were seen in this trial . Seven patients had stable disease ranging from 4 to 16 weeks ; no patient remained on therapy longer than 16 weeks due to the development of progressive disease . Conclusions This study suggests that while relatively nontoxic at a dose of 3 g/m2 per day , GTE likely has limited activity as a cytotoxic agent , and further study of GTE as a single-agent in established malignancies may not be warranted . Further studies should focus on the potential chemopreventive and chemotherapy-enhancing properties of GTE OBJECTIVES A two-stage , single-arm , phase II study was conducted to assess the effectiveness and safety of an epigallocatechin gallate (EGCG)-enriched tea drink , the double-brewed green tea ( DBGT ) , as a maintenance treatment in women with advanced stage serous or endometrioid ovarian cancer ( clinical trials.gov , NCT00721890 ) . METHODS Eligible women had FIGO stage III-IV serous or endometrioid ovarian cancer . They had to undergo complete response after debulking surgery followed by 6 to 8 cycles of platinum/taxane chemotherapy at the Centre Hospitalier Universitaire de Québec . They all had to drink the DBGT , 500 mL daily until recurrence or during a follow-up of 18 months . The primary endpoint was the absence of recurrence at 18 months . Statistical analyses were done according to the principle of intention to treat . Using a two-stage design , the first stage consisted of 16 enrolled patients . At the end of the follow-up , if 7 or fewer patients were free of recurrence , the trial stopped . Otherwise , accrual would continue to a total of 46 patients . RESULTS During the first stage of the study , only 5 of the 16 women remained free of recurrence 18 months after complete response . Accordingly , the clinical trial was terminated . Women 's adherence to DBGT  was high ( median daily intake during intervention , 98.1 % , interquartile range : 89.7 - 100 % ) , but 6 women discontinued the intervention before the end of their follow-up . No severe toxicity was reported . CONCLUSIONS DBGT supplementation does not appear to be a promising maintenance intervention in women with advanced stage ovarian cancer after st and ard treatment Epidemiologic and animal studies suggest a protective role of green tea against breast cancer . However , the underlying mechanism is not understood . We conducted a r and omized , double-blinded , placebo-controlled phase II clinical trial to investigate whether supplementation with green tea extract ( GTE ) modifies mammographic density ( MD ) , as a potential mechanism , involving 1,075 healthy postmenopausal women . Women assigned to the treatment arm consumed daily 4 decaffeinated GTE capsules containing 1,315 mg total catechins , including 843 mg epigallocatechin-3-gallate ( EGCG ) for 12 months . A computer-assisted method ( Madena ) was used to assess MD in digital mammograms at baseline and month 12 time points in 932 completers ( 462 in GTE and 470 in placebo ) . GTE supplementation for 12 months did not significantly change percent MD ( PMD ) or absolute MD in all women . In younger women ( 50–55 years ) , GTE supplementation significantly reduced PMD by 4.40 % as compared with the placebo with a 1.02 % PMD increase from pre- to postintervention ( P = 0.05 ) , but had no effect in older women ( Pinteraction = 0.07 ) . GTE supplementation did not induce MD change in other subgroups of women stratified by catechol-O-methyltransferase genotype or level of body mass index . In conclusion , 1-year supplementation with a high dose of EGCG did not have a significant effect on MD measures in all women , but reduced PMD in younger women , an age-dependent effect similar to those of tamoxifen . Further investigation of the potential chemopreventive effect of green tea intake on breast cancer risk in younger women is warranted . Cancer Prev Res ; 10(12 ) ; 710–8 . © 2017 AACR Pre clinical , epidemiologic , and prior clinical trial data suggest that green tea catechins ( GTC ) may reduce prostate cancer risk . We conducted a placebo-controlled , r and omized clinical trial of Polyphenon E ( PolyE ) , a proprietary mixture of GTCs , containing 400 mg (−)-epigallocatechin-3-gallate ( EGCG ) per day , in 97 men with high- grade prostatic intraepithelial neoplasia ( HGPIN ) and /or atypical small acinar proliferation ( ASAP ) . The primary study endpoint was a comparison of the cumulative one-year prostate cancer rates on the two study arms . No differences in the number of prostate cancer cases were observed : 5 of 49 ( PolyE ) versus 9 of 48 ( placebo ) , P = 0.25 . A secondary endpoint comparing the cumulative rate of prostate cancer plus ASAP among men with HGPIN without ASAP at baseline , revealed a decrease in this composite endpoint : 3 of 26 ( PolyE ) versus 10 of 25 ( placebo ) , P < 0.024 . This finding was driven by a decrease in ASAP diagnoses on the Poly E ( 0/26 ) compared with the placebo arm ( 5/25 ) . A decrease in serum prostate-specific antigen ( PSA ) was observed on the PolyE arm [ −0.87 ng/mL ; 95 % confidence intervals ( CI ) , −1.66 to −0.09 ] . Adverse events related to the study agent did not significantly differ between the two study groups . Daily intake of a st and ardized , decaffeinated catechin mixture containing 400 mg EGCG per day for 1 year accumulated in plasma and was well tolerated but did not reduce the likelihood of prostate cancer in men with baseline HGPIN or ASAP . Cancer Prev Res ; 8(10 ) ; 879–87 . © 2015 AACR 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 r and omised , 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 r and omised 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 Purpose The Minnesota Green Tea Trial ( MGTT ) was a r and omized , placebo-controlled , double-blinded trial investigating the effect of daily green tea extract consumption for 12 months on biomarkers of breast cancer risk . Methods Participants were healthy postmenopausal women at high risk of breast cancer due to dense breast tissue with differing catechol-O-methyltransferase ( COMT ) genotypes . The intervention was a green tea catechin extract containing 843.0 ± 44.0 mg/day epigallocatechin gallate or placebo capsules for 1 year . Annual digital screening mammograms were obtained at baseline and month 12 , and fasting blood and 24-h urine sample s were provided at baseline and at months 6 and 12 . Primary endpoints included changes in percent mammographic density , circulating endogenous sex hormones , and insulin-like growth factor axis proteins ; secondary endpoints were changes in urinary estrogens and estrogen metabolites and circulating F2-isoprostanes , a biomarker of oxidative stress . Results The MGTT screened more than 100,000 mammograms and r and omized 1,075 participants based on treatment  ( green tea extract vs. placebo ) , stratified by COMT genotype activity ( high COMT vs. low/intermediate COMT genotype activity ) . A total of 937 women successfully completed the study and 138 dropped out ( overall dropout rate = 12.8 % ) . Conclusions In this paper we report the rationale , design , recruitment , participant characteristics , and methods for biomarker and statistical analyses Se and green tea have been shown in epidemiological , observational and pre clinical studies to be inversely related to the risk of developing colorectal cancer ( CRC ) . However , there are limited studies to evaluate their regulatory effects on genes/proteins that relate to CRC oncogenesis in human subjects , such as selenoproteins , WNT signalling pathway , inflammation and methylation . This study examined the effects of supplementation of Se using Brazil nuts and green tea extract ( GTE ) capsules , alone and in combination , on targeted biomarkers . In total , thirty-two volunteers ( > 50 years of age ) with plasma Se≤1·36 µmol/l were r and omised to one of three treatment groups : nine to Se ( approximately 48 µg/d ) as six Brazil nuts , eleven to four GTE capsules ( 800 mg (-)-epigallocatechin-3-gallate ) and twelve to a combination of Brazil nuts and GTE . Blood and rectal biopsies were obtained before and after each intervention . Plasma Se levels , rectal selenoprotein P ( SePP ) and β-catenin mRNA increased significantly in subjects consuming Brazil nuts alone or in combination , whereas rectal DNA methyltransferase ( DNMT1 ) and NF-κB mRNA were reduced significantly in subjects consuming GTE alone or in combination . None of the interventions significantly affected rectal acetylated histone H3 or Ki-67 expression at the protein level or plasma C-reactive protein . Effects of the combination of Brazil nuts and GTE did not differ from what would be expected from either agent alone . In conclusion , supplementation of Brazil nuts and /or GTE regulates targeted biomarkers related to CRC oncogenesis , specifically genes associated with selenoproteins ( SePP ) , WNT signalling ( β-catenin ) , inflammation ( NF-κB ) and methylation ( DNMT1 ) . Their combination does not appear to provide additional effects compared with either agent alone PURPOSE To evaluate the efficacy and toxicity of green tea , prescribed as an alternative complementary ( CAM ) formulation on hormone refractory prostate cancer ( HRPC ) . METHODS Patients with HRCP were prescribed green tea extract capsules at a dose level of 250 mg twice daily . Efficacy and toxicity were evaluated during monthly visits . The primary endpoint was prostate-specific antigen ( PSA ) or measurable disease progression after a minimum of 2 months of therapy . RESULTS Nineteen patients were enrolled into the study . The treatment was generally well tolerated . Twelve patients reported at least one side effect ; only two of these were of moderate or severe grade . Primary toxicity was related to gastrointestinal irritation or caffeine intake . Four patients did not complete the minimum 2 months of therapy because of : intolerance ( two patients ) , physician stoppage ( one patient ) , death from cerebrovascular accident 
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Conclusions : The results of this study will contribute to the underst and ing of the efficacy of GTE in the setting of cancers and promote future research of GTE in patients with cancers .