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Trial Title:
Chemoprevention of Esophageal Squamous Cell Carcinoma (ESCC) With Aspirin and Tea Polyphenols
NCT ID:
NCT01496521
Condition:
Carcinoma, Squamous Cell
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Aspirin
Conditions: Keywords:
Aspirin
polyphenols
Chemoprevention
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Aspirin
Description:
100mg qd for 6 months.
Arm group label:
Aspirin
Intervention type:
Dietary Supplement
Intervention name:
Tea Polyphenols
Description:
300mg bid for 6 months.
Arm group label:
Tea Polyphenols
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
40 Years
Maximum age:
60 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Beijing Friendship Hospital Capital Medical University
Address:
City:
Beijing
Zip:
100050
Country:
China
Start date:
January 2012
Completion date:
January 2013
Lead sponsor:
Agency:
Beijing Friendship Hospital
Agency class:
Other
Source:
Beijing Friendship Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01496521
