Trial reportCancer prevention research (Philadelphia, Pa.)2015
Phase Ib Randomized, Double-Blinded, Placebo-Controlled, Dose Escalation Study of Polyphenon E in Patients with Barrett's Esophagus.
Trial report in Cancer prevention research (Philadelphia, Pa.), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.
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
20 citing papers in PubMed, 30 citations in OpenAlex.
- Randomized Controlled Trial of the Gastrin/CCKCancer prevention research (Philadelphia, Pa.) · 2021Trial
- Randomized Phase II Trial of Polyphenon E versus Placebo in Patients at High Risk of Recurrent Colonic Neoplasia.Cancer prevention research (Philadelphia, Pa.) · 2021Trial
- Catechins and Human Health: Breakthroughs from Clinical Trials.Molecules (Basel, Switzerland) · 2025Review
- Therapeutic potential of flavonoids in gastrointestinal cancer: Focus on signaling pathways and improvement strategies (Review).Molecular medicine reports · 2025Review
- Translating Molecular Biology Discoveries to Develop Targeted Cancer Interception in Barrett's Esophagus.International journal of molecular sciences · 2023Review
- Epigallocatechin-3-Gallate Therapeutic Potential in Cancer: Mechanism of Action and Clinical Implications.Molecules (Basel, Switzerland) · 2023Review
- Chemoprevention in Barrett's esophagus and esophageal adenocarcinoma.Therapeutic advances in gastroenterology · 2021Review
- Review
- Green Tea Polyphenols Modify the Gut Microbiome in db/db Mice as Co-Abundance Groups Correlating with the Blood Glucose Lowering Effect.Molecular nutrition & food research · 2019Article
- Inhibitory Effects of (-)-Epigallocatechin-3-gallate on Esophageal Cancer.Molecules (Basel, Switzerland) · 2019Review
- Chemoprevention of Barrett's Esophagus and Esophageal Adenocarcinoma.Digestive diseases and sciences · 2018Review
- Scientific opinion on the safety of green tea catechins.EFSA journal. European Food Safety Authority · 2018Article
- Antimetabolic Effects of Polyphenols in Breast Cancer Cells: Focus on Glucose Uptake and Metabolism.Frontiers in nutrition · 2018Review
- Studies on prevention of obesity, metabolic syndrome, diabetes, cardiovascular diseases and cancer by tea.Journal of food and drug analysis · 2018Review
- Formulation and characterization of EGCG for the treatment of superficial bladder cancer.International journal of molecular medicine · 2017Article
- The roles of epigallocatechin-3-gallate in the treatment of neuropathic pain: an update on preclinical in vivo studies and future perspectives.Drug design, development and therapy · 2017Review
- ErbB Proteins as Molecular Target of Dietary Phytochemicals in Malignant Diseases.Journal of oncology · 2017Review
- Cancer Preventive Activities of Tea Catechins.Molecules (Basel, Switzerland) · 2016Review
- The evidence for natural therapeutics as potential anti-scarring agents in burn-related scarring.Burns & trauma · 2016Review
- Evidence of Potential Natural Products for the Management of Hypertrophic Scars.Journal of evidence-based integrative medicineReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
23 authors at 7 institutions in 2 countries.
Funding
Abstract
This study was conducted to determine the safety and efficacy of the green tea-derived Polyphenon E (Poly E) in patients with Barrett's Esophagus (BE). Subjects were randomized to a 6-month, twice daily (BID) oral treatment of placebo or Poly E (200, 400, or 600 mg). Endoscopic evaluation, including biopsies, was performed before and after treatment. The primary objective was to demonstrate safety; secondary objectives investigated catechin accumulation and effects in clinical specimens. Of the 44 enrolled subjects, 11 received placebo, and 33 received Poly E. No dose-limiting toxicities were encountered, and a maximum tolerated dose (MTD) was not reached. The recommended phase II dose was 600 mg twice daily. The most common treatment-related adverse events (AE) in Poly E-treated subjects were grade I and II nausea, grade I belching, and grade I lactate dehydrogenase (LDH) elevation. No treatment-related AEs were reported in placebo-treated subjects, aside from grade I laboratory abnormalities. Pill counts and subject diaries were not consistently collected, and compliance was difficult to determine. However, on the basis of an intention-to-treat analysis, there was a significant relationship between Poly E dose and esophageal EGCG level--mean changes (pmol/g) of 0.79 (placebo), 6.06 (200 mg), 35.67 (400 mg), and 34.95 (600 mg); P = 0.005. There was a possible relationship between Poly E dose and urine PGE-M concentration. In conclusion, Poly E was well-tolerated, and treatment with Poly E (400 and 600 mg) but not Poly E (200 mg) or placebo resulted in clinically relevant and detectable EGCG accumulation in the target organ, esophageal mucosa.
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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.