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

• ClinicalTrials.gov Identifier: NCT01496521
• Recruitment Status: Unknown
• First Posted: December 21, 2011
• Last Update Posted: December 21, 2011
• Sponsor: Beijing Friendship Hospital
• Information provided by (Responsible Party): Shu-Tian Zhang, Beijing Friendship Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Carcinoma, Squamous Cell	Drug: Aspirin; Dietary Supplement: Tea Polyphenols	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 600 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (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.
• Study Start Date: January 2012
• Estimated Primary Completion Date: June 2012
• Estimated Study Completion Date: January 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: Aspirin	Drug: Aspirin; 100mg qd for 6 months.
Experimental: Tea Polyphenols	Dietary Supplement: Tea Polyphenols; 300mg bid for 6 months.
No Intervention: Control

Outcome Measures

Primary Outcome Measures :

1. occurrence of high grade dysplasia and invasive ESCC [ Time Frame: at six months ]

Secondary Outcome Measures :

1. the mortality of the participants [ Time Frame: The first interval will be at six months and the second at 3 or 5 years later. ]
2. 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. ]
3. occurrence of high grade dysplasia and invasive ESCC [ Time Frame: at 3 or 5 years later ]

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Contacts

Contact: Shu-Tian Zhang, MD; +86 010 63138067; drzstbj@126.com

Locations

China

Beijing Friendship Hospital Capital Medical University

Beijing, China, 100050

Sponsors and Collaborators

Beijing Friendship Hospital

Investigators

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

More Information

• Responsible Party: Shu-Tian Zhang, Professor, Beijing Friendship Hospital
• ClinicalTrials.gov Identifier: NCT01496521
• Other Study ID Numbers: CREAT
• First Posted: December 21, 2011
• Last Update Posted: December 21, 2011
• Last Verified: December 2011

Keywords provided by Shu-Tian Zhang, Beijing Friendship Hospital:

Aspirin; polyphenols; Chemoprevention

Additional relevant MeSH terms:

Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Aspirin; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; 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