Clinical trial · Interventional
Green Tea Extract in Treating Patients With Nonmetastatic Bladder Cancer
A Phase II Randomized, Placebo-Controlled Trial of Polyphenon E to Evaluate Bladder Tissue Levels of EGCG
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Green tea extract contains ingredients that may slow the growth of certain cancers. It is not yet known whether green tea extract is more effective than a placebo when given before surgery in treating patients with bladder. This randomized phase II trial is studying green tea extract to see how well it works compared to a placebo when given before surgery in treating patients with nonmetastatic bladder cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage I Bladder Cancer | Malignant Bladder Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Bladder Cancer | Malignant Bladder Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Bladder Cancer | Malignant Bladder Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Defined Green Tea Catechin Extract | Dietary Supplement | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Pharmacological Study | Other | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
| Therapeutic Conventional Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- PLACEBO_COMPARATOR
- label
- Arm I (placebo)
- description
- Patients receive six oral placebo capsules once daily for 14-28 days.
- interventionNames
- Other: Laboratory Biomarker Analysis
- Other: Pharmacological Study
- Drug: Placebo
- type
- EXPERIMENTAL
- label
- Arm II (polyphenon E, placebo)
- description
- Patients receive four oral polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.
- interventionNames
- Dietary Supplement: Defined Green Tea Catechin Extract
- Other: Laboratory Biomarker Analysis
- Other: Pharmacological Study
- Drug: Placebo
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Criteria: * Diagnosis of bladder cancer * Bladder tumor discovered on cystoscopy within the past 60 days * Invasive or non-invasive tumor * Primary tumor may represent either an initial diagnosis or recurrent disease of any clinical stage * No metastatic disease * Must be an eligible candidate for a partial cystectomy, radical cystectomy, or trans-urethral resection of bladder tumor (TURBT) * Has not undergone any treatment for superficial or invasive bladder cancer since the diagnostic cystoscopy * TURBT or radical cystectomy is the planned curative surgical treatment * ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100% * More than 30 days since any prior intravesical therapy or adjuvant chemotherapy * More than 30 days since prior bladder surgery * Biopsies are not considered surgeries * No prior pelvic radiotherapy * No concurrent systemic chemotherapy for any other cancer, except nonmelanoma skin cancer * No concurrent NSAIDs (e.g., ibuprofen, naproxen, or cyclooxygenase-2 inhibitors) except =\< 81 mg aspirin per day * Concurrent acetaminophen (Tylenol) or prescription opioids combined with acetaminophen (i.e., Percocet, Darvocet, Vicodin, Tylenol #3) allowed for pain * No other concurrent investigational agents * White Blood Cell (WBC) \>= 3,000/mm\^3 * Platelet count \>= 100,000/mm\^3 * Hemoglobin \>= 10 g/dL * Alkaline phosphatase =\< upper limit of normal (ULN) * Bilirubin =\< ULN * Asparate Aminotransferase (AST) and Alanine Transaminase (ALT) =\< ULN * Sodium 135-144 mmol/L (inclusive) * Potassium 3.2-4.8 mmol/L (inclusive) * Chloride 85-114 mmol/L (inclusive) * Bicarbonate \>11 mEQ/dL * Negative pregnancy test * Fertile patients must use effective contraception * Willing to avoid green tea beverages and green tea-containing products during study participation * No evidence of other cancers, except nonmelanoma skin cancer * No history of allergic reactions attributed to tea or to any of the compounds of similar chemical or biologic composition to Polyphenon E or any of the inactive ingredients in Polyphenon E capsules * No uncontrolled intercurrent illness including, but not limited to, any of the following: Ongoing or active infection, Symptomatic congestive heart failure, Unstable angina pectoris, Cardiac arrhythmia, Psychiatric illness/social situations that would limit study compliance * More than 24 hours since prior and no concurrent consumption of any other green tea supplements or more than 2 cups (16 oz) of green tea either through dietary sources or through nutritional supplementation * Topical cosmetics (i.e., lotions, shampoos, makeup) that contain green tea are allowed * Creatinine normal * Not pregnant or nursing
References
Publications (0)
Data not yet available