NCT00573885

Brief Summary

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. Green tea extract may keep cancer from forming. PURPOSE: This randomized phase II trial is studying green tea extract in preventing cancer in former and current heavy smokers with abnormal sputum.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P50-P75 for phase_2 lung-cancer

Timeline
Completed

Started Jan 2008

Shorter than P25 for phase_2 lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 14, 2007

Completed
18 days until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

March 9, 2012

Status Verified

March 1, 2012

Enrollment Period

10 months

First QC Date

December 13, 2007

Last Update Submit

March 7, 2012

Conditions

Lung CancerTobacco Use Disorder

Keywords

non-small cell lung cancersmall cell lung cancertobacco use disorder

Outcome Measures

Primary Outcomes (4)

  • Changes in oncogene/tumor suppression gene expression (part 1; completed March 22, 2006)

    36 months

  • Phase I and II enzyme regulation by Affymetrix chip analysis in bronchial brush cells (part 1)

    60 months

  • C-reactive protein level in plasma before treatment and 1 and 2 months after treatment (part 1)

    60 months

  • Quantitative sputum score by image analysis before and 6 months after treatment (part 2)

    36 months

Secondary Outcomes (9)

  • Change in pathology grade of bronchial biopsies (part 2)

    36 months

  • Morphometric index of bronchial biopsies and bronchoalveolar lavage cells (BAL) (part 2)

    36 months

  • Methylation markers in sputa and BAL cells (part 2)

    60 months

  • Ki-67 expression (part 2)

    60 months

  • Cleaved caspase 3, p53, and VEGF assays in bronchial biopsies (part 2)

    60 months

  • +4 more secondary outcomes

Study Arms (2)

Arm I

EXPERIMENTAL

Patients receive oral defined green tea catechin extract twice daily for 6 months.

Drug: defined green tea catechin extract

Arm II

PLACEBO COMPARATOR

Patients receive oral placebo twice daily for 6 months.

Other: placebo

Interventions

defined green tea catechin extractDRUG

Given orally

Arm I
placeboOTHER

Given orally

Arm II

Eligibility Criteria

Age45 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ECOG performance status 0-1
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Creatinine normal
  • Bilirubin normal
  • AST and ALT normal
  • Alkaline phosphatase normal

You may not qualify if:

  • Chronic active hepatitis/liver cirrhosis
  • Severe heart disease (e.g., unstable angina, chronic congestive heart failure, use of antiarrhythmic agents)
  • Ongoing gastric ulcer
  • Acute bronchitis or pneumonia within one month
  • Known reaction to lidocaine, albuterol sulfate, midazolam hydrochloride, and/or alfentanil hydrochloride
  • Known allergy to green tea and/or corn starch, gelatin, or other nonmedicinal ingredients
  • Any medical condition, such as acute or chronic respiratory failure or bleeding disorder that, in the opinion of the investigator, could jeopardize the patient's safety during participation in the study
  • Unwilling to have a bronchoscopy
  • Unwilling to have a spiral chest CT
  • PRIOR CONCURRENT THERAPY:
  • No more than 5 cups of tea a week
  • No concurrent anticoagulant treatment such as warfarin or heparin
  • No use of other natural health products containing green tea compounds

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

British Columbia Cancer Agency - Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

MeSH Terms

Conditions

Lung NeoplasmsTobacco Use DisorderCarcinoma, Non-Small-Cell LungSmall Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesSubstance-Related DisordersChemically-Induced DisordersMental DisordersCarcinoma, BronchogenicBronchial Neoplasms

Study Officials

  • Stephen Lam, MD

    British Columbia Cancer Agency

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2007

First Posted

December 14, 2007

Study Start

January 1, 2008

Primary Completion

November 1, 2008

Study Completion

December 1, 2008

Last Updated

March 9, 2012

Record last verified: 2012-03

Locations

CA(1)