Chemoprevention of Esophageal Squamous Cell Carcinoma (ESCC) With Aspirin and Tea Polyphenols
Status:
Unknown status
Trial end date:
2013-01-01
Target enrollment:
Participant gender:
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.