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