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

NCT ID: NCT01496521

Last Updated: 2011-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-01-31

Brief Summary

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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

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Conditions

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Carcinoma, Squamous Cell

Keywords

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Aspirin polyphenols Chemoprevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Aspirin

Group Type EXPERIMENTAL

Aspirin

Intervention Type DRUG

100mg qd for 6 months.

Tea Polyphenols

Group Type EXPERIMENTAL

Tea Polyphenols

Intervention Type DIETARY_SUPPLEMENT

300mg bid for 6 months.

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Aspirin

100mg qd for 6 months.

Intervention Type DRUG

Tea Polyphenols

300mg bid for 6 months.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beijing Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

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Shu-Tian Zhang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shu-Tian Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Friendship Hospital

Locations

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Beijing Friendship Hospital Capital Medical University

Beijing, , China

Site Status

Countries

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China

Central Contacts

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Shu-Tian Zhang, MD

Role: CONTACT

Phone: +86 010 63138067

Email: [email protected]

Other Identifiers

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CREAT

Identifier Type: -

Identifier Source: org_study_id