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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2011 by Beijing Friendship Hospital.
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
Shu-Tian Zhang, Beijing Friendship Hospital Identifier:
First received: December 15, 2011
Last updated: December 17, 2011
Last verified: December 2011
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.

Condition Intervention Phase
Carcinoma, Squamous Cell
Drug: Aspirin
Dietary Supplement: Tea Polyphenols
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Chemoprevention of Esophageal Squamous Cell Carcinoma With Aspirin and Tea Polyphenols: a Randomized Controlled Trial.

Resource links provided by NLM:

Further study details as provided by Beijing Friendship Hospital:

Primary Outcome Measures:
  • occurrence of high grade dysplasia and invasive ESCC [ Time Frame: at six months ]

Secondary Outcome Measures:
  • the mortality of the participants [ Time Frame: 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. ]
  • occurrence of high grade dysplasia and invasive ESCC [ Time Frame: at 3 or 5 years later ]

Estimated Enrollment: 600
Study Start Date: January 2012
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aspirin Drug: Aspirin
100mg qd for 6 months.
Experimental: Tea Polyphenols Dietary Supplement: Tea Polyphenols
300mg bid for 6 months.
No Intervention: Control


Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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.
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Please refer to this study by its identifier: NCT01496521

Contact: Shu-Tian Zhang, MD +86 010 63138067

Beijing Friendship Hospital Capital Medical University Not yet recruiting
Beijing, China, 100050
Sponsors and Collaborators
Beijing Friendship Hospital
Principal Investigator: Shu-Tian Zhang, MD Beijing Friendship Hospital
  More Information

Responsible Party: Shu-Tian Zhang, Professor, Beijing Friendship Hospital Identifier: NCT01496521     History of Changes
Other Study ID Numbers: CREAT
Study First Received: December 15, 2011
Last Updated: December 17, 2011

Keywords provided by Beijing Friendship Hospital:

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics processed this record on April 25, 2017