Clinical trial · Interventional
Green Tea Extract in Treating Current or Former Smokers With Bronchial Dysplasia
Phase II Trial of Polyphenon E in Current and Former Smokers With Bronchial Dysplasia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow recruitment
Summary
Brief summary (as posted)
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of Polyphenon E, a substance found in green tea, may keep cancer from forming in current or former smokers with bronchial dysplasia. PURPOSE: This randomized phase II trial is studying the side effects and how well green tea extract works in treating current or former smokers with bronchial dysplasia.
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 |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Precancerous Condition | — | UNRESOLVED | — |
| Tobacco Use Disorder | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| defined green tea catechin extract | Drug | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive oral Polyphenon E twice daily for 3 months in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: defined green tea catechin extract
- type
- PLACEBO_COMPARATOR
- label
- Arm II
- description
- Patients receive a placebo twice daily for 3 months in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Other: placebo
Primary outcomes (1)
- measure
- Change in the severity of dysplasia (as defined by WHO criteria) in bronchial biopsy specimens as assessed at baseline and at 3 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
- Maximum age
- 74 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Current or former smoker who has smoked ≥ 30 pack-years (i.e., 1 pack per day for ≥ 30 years) * A former smoker is defined as one who has stopped smoking for ≥ 1 year * C-reactive protein level \> 1.2 mg/L * One or more areas of dysplasia with a surface diameter \> 1.2 mm on autofluorescence bronchoscopy * No carcinoma in situ or invasive cancer on bronchoscopy * No abnormal spiral chest CT scan suspicious of lung cancer PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Willing to take Polyphenon E or placebo twice a day regularly * Willing to undergo bronchoscopy and spiral chest CT scan * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Creatinine normal * Bilirubin normal * AST and ALT normal * Alkaline phosphatase normal * No chronic active hepatitis or liver cirrhosis * No severe heart disease (e.g., unstable angina or chronic congestive heart failure) * No ongoing gastric ulcer * No acute bronchitis or pneumonia within the past month * No known reaction to xylocaine, salbutamol, midazolam, or alfentanil * No known allergy to green tea and/or corn starch, gelatin, or other nonmedicinal ingredients * No medical condition, such as acute or chronic respiratory failure or bleeding disorder, that, in the opinion of the investigator, could jeopardize patient safety during study participation PRIOR CONCURRENT THERAPY: * No concurrent consumption of \> 7 cups of tea a week * No other concurrent natural health products containing green tea compounds * No concurrent antiarrhythmic agents * No concurrent anticoagulants, such as warfarin or heparin
References
Publications (0)
Data not yet available