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

December 17, 2011 updated by: Shu-Tian Zhang, Beijing Friendship Hospital

Chemoprevention of Esophageal Squamous Cell Carcinoma With Aspirin and Tea Polyphenols: a Randomized Controlled Trial.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100050
        • Beijing Friendship Hospital Capital Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Aspirin
Drug: Aspirin
100mg qd for 6 months.
Experimental: Tea Polyphenols
Dietary supplement: Tea Polyphenols
300mg bid for 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
occurrence of high grade dysplasia and invasive ESCC
Time Frame: at six months
at six months

Secondary Outcome Measures

Outcome Measure
Time Frame
the mortality of the participants
Time Frame: The first interval will be at six months and the second at 3 or 5 years later.
The first interval will be at six months and the second at 3 or 5 years later.
Number of participants with adverse events.
Time Frame: The first interval will be at six months and the second at 3 or 5 years later.
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
Time Frame: at 3 or 5 years later
at 3 or 5 years later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Friendship Hospital

Investigators

  • Principal Investigator: Shu-Tian Zhang, MD, Beijing Friendship Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

June 1, 2012

Study Completion (Anticipated)

January 1, 2013

Study Registration Dates

First Submitted

December 15, 2011

First Submitted That Met QC Criteria

December 17, 2011

First Posted (Estimate)

December 21, 2011

Study Record Updates

Last Update Posted (Estimate)

December 21, 2011

Last Update Submitted That Met QC Criteria

December 17, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CREAT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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