Carcinoma, Squamous Cell
Conditions
Keywords
Aspirin, polyphenols, Chemoprevention
Brief 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.
Interventions
DRUGAspirin
100mg qd for 6 months.
DIETARY_SUPPLEMENTTea Polyphenols
300mg bid for 6 months.
Sponsors
Beijing Friendship Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| occurrence of high grade dysplasia and invasive ESCC | at six months |
Secondary
| Measure | Time frame |
|---|---|
| the mortality of the participants | The first interval will be at six months and the second at 3 or 5 years later. |
| Number of participants with adverse events. | The first interval will be at six months and the second at 3 or 5 years later. |
| occurrence of high grade dysplasia and invasive ESCC | at 3 or 5 years later |
Countries
China
Contacts
Primary ContactShu-Tian Zhang, MD
Outcome results
None listed