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

Phase 3

• Conditions: Carcinoma, Squamous Cell
• Interventions: Dietary Supplement: Tea Polyphenols; Drug: Aspirin

• Registration Number: NCT01496521
• Lead Sponsor: Beijing Friendship Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-12
• Study First Submitted: 2011-12-15
• Study First Submitted QC: 2011-12-17
• Last Update Submitted: 2011-12-17
• Study First Posted: 2011-12-21
• Last Update Posted: 2011-12-21
• Study Start: 2012-01
• Primary Completion: 2012-06
• Study Completion: 2013-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tea Polyphenols	Tea Polyphenols	-
Aspirin	Aspirin	-

Primary Outcome Measures

Name	Time	Method
occurrence of high grade dysplasia and invasive ESCC	at six months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Beijing Friendship Hospital Capital Medical University; 🇨🇳 Beijing, China