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

This study is not yet open for participant recruitment.
Verified December 2011 by Beijing Friendship Hospital
Sponsor:
Information provided by (Responsible Party):
Shu-Tian Zhang, Beijing Friendship Hospital
ClinicalTrials.gov Identifier:
NCT01496521
First received: December 15, 2011
Last updated: December 17, 2011
Last verified: December 2011
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

Drug Information available for: Aspirin
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: Yes ]
  • occurrence of high grade dysplasia and invasive ESCC [ Time Frame: at 3 or 5 years later ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   40 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01496521

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

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

No publications provided

Responsible Party: Shu-Tian Zhang, Professor, Beijing Friendship Hospital
ClinicalTrials.gov Identifier: NCT01496521     History of Changes
Other Study ID Numbers: CREAT
Study First Received: December 15, 2011
Last Updated: December 17, 2011
Health Authority: China:Capital Medical University

Keywords provided by Beijing Friendship Hospital:
Aspirin
polyphenols
Chemoprevention

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 23, 2013