Trial reportCancer prevention research (Philadelphia, Pa.)2009
Phase II randomized, placebo-controlled trial of green tea extract in patients with high-risk oral premalignant lesions.
Trial report in Cancer prevention research (Philadelphia, Pa.), 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 102 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
102 citing papers in PubMed, 3 syntheses or guidelines pooled it, 248 citations in OpenAlex.
- Green tea (Camellia sinensis) for the prevention of cancer.The Cochrane database of systematic reviews · 2020Pooled it
- Liver-related safety assessment of green tea extracts in humans: a systematic review of randomized controlled trials.European journal of clinical nutrition · 2016Pooled it
- Tea consumption and the risk of five major cancers: a dose-response meta-analysis of prospective studies.BMC cancer · 2014Pooled it
- Topical application of a mucoadhesive freeze-dried black raspberry gel induces clinical and histologic regression and reduces loss of heterozygosity events in premalignant oral intraepithelial lesions: results from a multicentered, placebo-controlled clinical trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2014Trial
- Trial
- A six-month crossover chemoprevention clinical trial of tea in smokers and non-smokers: methodological issues in a feasibility study.BMC complementary and alternative medicine · 2012Trial
- Gene expression profiling predicts the development of oral cancer.Cancer prevention research (Philadelphia, Pa.) · 2011Trial
- Network Pharmacology-Guided Phytochemical Polypharmacology: Integrating Molecular Mechanisms, Experimental Validation and Clinical Translation.International journal of molecular sciences · 2026Review
- From Chronic Inflammation to Malignancy: Molecular Mechanisms and Therapeutic Insights in Oral Carcinogenesis.International journal of molecular sciences · 2026Review
- Article
- The potential and promise of natural antioxidants as epigenetic modulators in oral squamous cell carcinoma.Cancer chemotherapy and pharmacology · 2026Review
- Anti-cancer effects of plant extracts in head and neck squamous cell carcinoma.Frontiers in pharmacology · 2026Review
- A spatial-microbial-metabolic-immune framework for high-risk oral potentially malignant disorders: an evidence-ranked review for malignant transformation risk stratification.Frontiers in cellular and infection microbiology · 2026Review
- Angiogenesis as a Therapeutic Target of (Poly)phenols: Tackling Cancer and Vascular-Related Complications.Molecular nutrition & food research · 2025Review
- Suppression of Cellular Proliferation in PC3 Prostate Cancer Cells by Green Tea Extract Through Induction of miR-34a Expression.Food science & nutrition · 2025Article
- Oxidative Stress and Dietary Antioxidants in Head and Neck Cancer.Antioxidants (Basel, Switzerland) · 2025Review
- Beyond Conventional Treatments: The Role of Complementary Therapies in Head and Neck Cancer.Cancers · 2025Review
- Chemoprevention of Head and Neck Cancer: A Review of Current Approaches and Future Perspectives.Cancer prevention research (Philadelphia, Pa.) · 2024Review
- Oral Health and Nutraceutical Agents.International journal of molecular sciences · 2024Review
- Oral Pre-malignancy: An Update on Novel Therapeutic Approaches.Current oncology reports · 2024Review
42 more citing papers are in PubMed but not listed here.
Corrections and comments
- Commented on by
Authors and funding
13 authors at 1 institution in 1 country.
Funding
Abstract
Epidemiologic and preclinical data support the oral cancer prevention potential of green tea extract (GTE). We randomly assigned patients with high-risk oral premalignant lesions (OPL) to receive GTE at 500, 750, or 1,000 mg/m(2) 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/m(2)), 36.4% (500 mg/m(2)), 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 clinically 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.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.