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Chemoprevention of Esophageal Squamous Cell Carcinoma (ESCC) With Aspirin and Tea Polyphenols — CREAT  

Carcinoma, Squamous Cell Clinical Trial

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

Clinical Trial Summary

Evidence from laboratory studies suggests that aspirin and tea polyphenols may have an antineoplastic effect in esophageal squamous cell carcinoma (ESCC). To assess the safety and efficacy of aspirin and tea polyphenols for preventing ESCC, the investigators designed this double-blind, randomized controlled clinical trial. Research project is planned to recruit 10,000 participants with the ages of 40-60 years in Fengfeng city, Hebei province, China, which has been known as a high incidence region of ESCC. All the participants receive endoscopic examination. Lugol's chromoendoscopy is used to identify esophageal unstained lesions (USLs). The location and size of each USL will be recorded followed by collecting biopsy samples from each USL. Participants with USL are randomly assigned to receive 100 mg/d of aspirin (n=200), 100 mg/d of tea polyphenols (n=200), or placebo (n=200) for six months. Follow-up consists of 2 endoscopic surveillance cycles (the first interval will be at six months and the second at 3 or 5 years later). The primary outcome measure was occurrence of high grade dysplasia and invasive ESCC. Secondary outcome was the mortality of the participants and adverse events.

Clinical Trial Description

n/a

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01496521
Study type Interventional
Source Beijing Friendship Hospital
Contact Shu-Tian Zhang, MD
Phone +86 010 63138067
Email drzstbj@126.com
Status Not yet recruiting
Phase Phase 3
Start date January 2012
Completion date January 2013
View Details
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