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Chemoprevention of Esophageal Squamous Cell Carcinoma With Aspirin and Tea Polyphenols: a Randomized Controlled Trial.


Phase 3
40 Years
60 Years
Not Enrolling
Both
Carcinoma, Squamous Cell

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Trial Information

Chemoprevention of Esophageal Squamous Cell Carcinoma With Aspirin and Tea Polyphenols: a Randomized Controlled Trial.


Inclusion Criteria:



1. age 40 to 60 years;

2. Lugol's chromoendoscopy showing at least one USL 1 cm or larger containing mild to
moderate dysplasia and chronic inflammation;

3. subject neither pregnant nor intending to become pregnant during the study.

Exclusion Criteria:

1. current non-steroidal anti-inflammatory drugs (NSAID) therapy;

2. major intercurrent illness;

3. pregnancy;

4. invasive carcinoma;

5. any condition that could be worsened by aspirin or tea polyphenols.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

occurrence of high grade dysplasia and invasive ESCC

Outcome Time Frame:

at six months

Safety Issue:

No

Principal Investigator

Shu-Tian Zhang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beijing Friendship Hospital Capital Medical University

Authority:

China:Capital Medical University

Study ID:

CREAT

NCT ID:

NCT01496521

Start Date:

January 2012

Completion Date:

January 2013

Related Keywords:

  • Carcinoma, Squamous Cell
  • Aspirin
  • polyphenols
  • Chemoprevention
  • Carcinoma
  • Carcinoma, Squamous Cell

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