***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 
    ***DOCUMENTATION*** 
    ***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 Controlled trials that use r and omized allocation are the best tool to control for bias and confounding in trials testing clinical interventions . Investigators must be sure to include information that is required by the reader to judge the validity and implication s of the findings in the reports of these trials . In part , complete reporting of trials will allow clinicians to modify their clinical practice to reflect current evidence toward the improvement of clinical outcomes . The consoli date d st and ards of reporting trials ( CONSORT ) statement was developed to assist investigators , authors , review ers , and editors on the necessary information to be included in reports of controlled clinical trials . The CONSORT statement is applicable to any intervention , including herbal medicinal products . Controlled trials of herbal interventions do not adequately report the information suggested in CONSORT . Recently , reporting recommendations were developed in which several CONSORT items were elaborated to become relevant and complete for r and omized controlled trials of herbal medicines . We expect that these recommendations will lead to more complete and accurate reporting of herbal trials . We wrote this explanatory document to outline the rationale for each recommendation and to assist authors in using them by providing the CONSORT items and the associated elaboration , together with examples of good reporting and empirical evidence , where available , for each . These recommendations for the reporting of herbal medicinal products presented here are open to revision as more evidence accumulates and critical comments are collected The levels of tobacco-related DNA adducts in human tissues reflect a dynamic process that is dependent on the intensity and time of exposure to tobacco smoke , the metabolic balance between activation of detoxification mechanisms , and the removal of adducts by DNA repair and /or cell turnover . Urinary 8-hydroxydeoxyguanosine ( 8-OHdG ) is probably 1 of the most abundant DNA lesions formed during oxidative stress and is proposed as a sensitive biomarker of the overall oxidative DNA damage and repair . We performed this study to determine whether there were differences in increased oxidative stress susceptibility to smoking within the combined GSTM1 and hOGG1 genotypes and the impact of green tea drinking on this . We completed a Phase II r and omized , controlled , 3-arm tea intervention trial to study the effect of high consumption of decaffeinated green or black tea or water on urinary 8-OHdG among heavy smokers and to evaluate the roles of GSTM1 and hOGG1 genotypes as effect modifiers . Assessment of urinary 8-OHdG after adjustment for baseline measurements and other potential confounders revealed a significant effect of green tea consumption ( P = 0.001 ) . The change from baseline was significant in all GSTM1-positive smokers regardless of their hOGG1 genotype . Our data show that consumption of 4 cups ( 960 mL ) of tea/d is a feasible and safe approach and was associated with a significant decrease in urinary 8-OHdG among green tea consumers . Our finding also suggests that green tea intervention might be effective in decreasing DNA damage in the subgroup of smokers who are GSTM1 positive regardless of their hOGG1 genotype Tea drinking has been associated with decreased occurrence of cancer and heart disease . One potential mechanism for these findings is the strong antioxidant effect of tea polyphenols . A phase II r and omized controlled tea intervention trial was design ed to study the effect of high consumption ( 4 cups/d ) of decaffeinated green or black tea on oxidative DNA damage as measured by urinary 8-hydroxydeoxyguanosine ( 8-OHdG ) among smokers over a 4-mo period . A total of 143 heavy smokers , aged 18 - 79 y , were r and omized to drink either green or black tea or water . Levels of plasma and urinary catechins and urinary 8-OHdG were measured monthly . A total of 133 of 143 smokers completed the 4-mo intervention . Multiple linear regression models were used to estimate the main effects and interaction effect of green and black tea consumption on creatinine-adjusted urinary 8-OHdG , with or without adjustment for potential confounders . Plasma and urinary levels of catechins rose significantly in the green tea group compared with the other two groups . Assessment of urinary 8-OHdG after adjustment for baseline measurements and other potential confounders revealed a highly significant decrease in urinary 8-OHdG ( -31 % ) after 4 mo of drinking decaffeinated green tea ( P = 0.002 ) . No change in urinary 8-OHdG was seen among smokers assigned to the black tea group . These data suggest that regular green tea drinking might protect smokers from oxidative damages and could reduce cancer risk or other diseases caused by free radicals associated with smoking To examine whether weight loss at presentation influences outcome in patients who received chemotherapy for lung cancer or mesothelioma . Multivariate analysis of prospect ively collected data 1994–2001 . Data were available for age , gender , performance status , histology , stage , response , toxicity , progression-free and overall survival . The outcomes of patients with or without weight loss treated with chemotherapy for small cell lung cancer ( SCLC ; n=290 ) , stages III and IV non-small-cell lung cancer ( NSCLC ; n=418 ) , or mesothelioma ( n=72 ) were compared . Weight loss was reported by 59 , 58 and 76 % of patients with SCLC , NSCLC and mesothelioma , respectively . Patients with weight loss and NSCLC ( P=0.003 ) or mesothelioma ( P=0.05 ) more frequently failed to complete at least three cycles of chemotherapy . Anaemia as a toxicity occurred significantly more frequently in NSCLC patients with weight loss ( P=0.0003 ) . The incidence of other toxicities was not significantly affected by weight loss . NSCLC patients with weight loss had fewer symptomatic responses ( P=0.001 ) . Mesothelioma patients with weight loss had fewer symptomatic ( P=0.03 ) and objective responses ( P=0.05 ) . Weight loss was an independent predictor of shorter overall survival for patients with SCLC ( P=0.003 , relative risk (RR)=1.5 ) , NSCLC ( P=0.009 , RR=1.33 ) and mesothelioma ( P=0.03 , RR=1.92 ) and an independent predictor of progression-free survival in patients with SCLC ( P=0.01 , RR=1.43 ) . In conclusion , weight loss as a symptom of lung cancer predicts for toxicity from treatment and shorter survival Epidemiologic and pre clinical data support the oral cancer prevention potential of green tea extract ( GTE ) . We r and omly assigned patients with high-risk oral premalignant lesions ( OPL ) to receive GTE at 500 , 750 , or 1,000 mg/m2 or placebo thrice daily for 12 weeks , evaluating biomarkers in baseline and 12-week biopsies . The OPL clinical response rate was higher in all GTE arms ( n = 28 ; 50 % ) versus placebo ( n = 11 ; 18.2 % ; P = 0.09 ) but did not reach statistical significance . However , the two higher-dose GTE arms [ 58.8 % ( 750 and 1,000 mg/m2 ) , 36.4 % ( 500 mg/m2 ) , and 18.2 % ( placebo ) ; P = 0.03 ] had higher responses , suggesting a dose-response effect . GTE treatment also improved histology ( 21.4 % versus 9.1 % ; P = 0.65 ) , although not statistically significant . GTE was well tolerated , although higher doses increased insomnia/nervousness but produced no grade 4 toxicity . Higher mean baseline stromal vascular endothelial growth factor ( VEGF ) correlated with a clinical ( P = 0.04 ) but not histologic response . Baseline scores of other biomarkers ( epithelial VEGF , p53 , Ki-67 , cyclin D1 , and p16 promoter methylation ) were not associated with a response or survival . Baseline p16 promoter methylation ( n = 5 ) was associated with a shorter cancer-free survival . Stromal VEGF and cyclin D1 expression were downregulated in clinical ly responsive GTE patients and upregulated in nonresponsive patients at 12 weeks ( versus at baseline ) . An extended ( median , 27.5 months ) follow-up showed a median time to oral cancer of 46.4 months . GTE may suppress OPLs , in part through reducing angiogenic stimulus ( stromal VEGF ) . Higher doses of GTE may improve short-term ( 12-week ) OPL outcome . The present results support longer-term clinical testing of GTE for oral cancer prevention Glutathione S-transferase ( GST ) , a member of the phase II group of xenobiotic metabolizing enzymes , has been intensively studied at the levels of phenotype and genotype . The GST μ 1 ( GSTM1 ) and GST θ 1 ( GSTT1 ) genes have a null-allele variant in which the entire gene is absent . The null genotype for both enzymes has been associated with many different types of tumors . The aim of this study was to determine the possible differences in increased oxidative stress susceptibility to smoking within the GSTM1 and GSTT1 genotypes and the impact of high tea drinking on this . We design ed a Phase II r and omized , controlled , three-arm tea intervention trial to study the effect of high consumption ( 4 cups/day ) of decaffeinated green or black tea , or water on oxidative DNA damage , as measured by urinary 8-hydroxydeoxyguanosine ( 8-OHdG ) , among heavy smokers over a 4-month period and to evaluate the roles of GSTM1 and GSTT1 genotypes as effect modifiers . A total of 133 heavy smokers ( 100 females and 33 males ) completed the intervention .  GSTM1 and GSTT1 genotype statuses were determined with a PCR-based approach . Multiple linear regression models were used to estimate the main effects and interaction effect of green and black tea consumption on creatinine-adjusted urinary 8-OHdG , with or without adjustment for potential confounders . Finally , we studied whether the effect of treatment varied by GSTM1 and GSTT1 status of the individual . Although there were no differences in urinary 8-OHdG between the groups at baseline , the between-group 8-OHdG levels at month 4 were statistically significant for GSTM1-positive smokers ( P = 0.05 ) and GSTT1-positive smokers ( P = 0.02 ) . GSTM1-positive and GSTT1-positive smokers consuming green tea showed a decrease in urinary 8-OHdG levels after 4 months . Assessment of urinary 8-OHdG after adjustment for baseline measurements and other potential confounders revealed significant effect for green tea consumption ( P = 0.001 ) . The change from baseline was significant in both GSTM1-positive ( t = −2.99 ; P = 0.006 ) and GSTT1-positive ( P = 0.004 ) green tea groups , but not in the GSTM1-negative ( P = 0.07 ) or GSTT1-negative ( P = 0.909 ) green tea groups . Decaffeinated black tea consumption had no effect on urinary 8-OHdG levels among heavy smokers . Our data show that consumption of 4 cups of tea/day is a feasible and safe approach and is associated with a significant decrease in urinary 8-OHdG among green tea consumers after 4 months of consumption . This finding also suggests that green tea intervention may be effective in the subgroup of smokers who are GSTM1 and /or GSTT1 positive PURPOSE This trial was design ed to determine the maximum-tolerated dose , toxicity , and pharmacology of oral green tea extract ( GTE ) once daily or three times daily . PATIENTS AND METHODS Cohorts of three or more adult cancer patients were administered oral GTE with water after meals one or three times daily for 4 weeks , to a maximum of 6 months , depending on disease response and patient tolerance . Pharmacok 
    Output:
    
Four cups of green tea daily decreased DNA damage ( 8OH-dG ) in smokers .
Human studies indicate that 800 mg of green tea catechins daily does not alter activity of the CYP2D6 , CYP1A2 , CYP3A4 and CYP2C9 enzymes , however in vitro evidence suggests that green tea may bind to and reduce the effectiveness of bortezomib .
Green tea applied topically may improve the healing time of radiation burns .
Conclusions : Although some evidence suggests that chemopreventative benefits can be accrued from green tea , there is currently insufficient evidence to support green tea as a treatment or preventative agent for lung cancer .