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

NCT01496521 | Unknown Phase 3 DMC

• 1 other identifier: CREAT
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma, Squamous Cell

Keywords

Aspirin; polyphenols; Chemoprevention

Outcome Measures

Primary Outcomes (1)

• occurrence of high grade dysplasia and invasive ESCC

  at six months

Secondary Outcomes (3)

• the mortality of the participants

  The first interval will be at six months and the second at 3 or 5 years later.

• Number of participants with adverse events.

  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

  at 3 or 5 years later

Study Arms (3)

Aspirin

EXPERIMENTAL

Drug: Aspirin

Tea Polyphenols

EXPERIMENTAL

Dietary Supplement: Tea Polyphenols

Control

NO INTERVENTION

Interventions

Aspirin DRUG

100mg qd for 6 months.

Aspirin

Tea Polyphenols DIETARY_SUPPLEMENT

300mg bid for 6 months.

Tea Polyphenols

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age 40 to 60 years;
• Lugol's chromoendoscopy showing at least one USL 1 cm or larger containing mild to moderate dysplasia and chronic inflammation;
• subject neither pregnant nor intending to become pregnant during the study.

You may not qualify if:

• current non-steroidal anti-inflammatory drugs (NSAID) therapy;
• major intercurrent illness;
• pregnancy;
• invasive carcinoma;
• any condition that could be worsened by aspirin or tea polyphenols.

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Beijing Friendship Hospital Capital Medical University

Beijing, 100050, China

Location

MeSH Terms

Conditions

Carcinoma, Squamous Cell

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Shu-Tian Zhang, MD

  Beijing Friendship Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shu-Tian Zhang, MD

CONTACT

+86 010 63138067; drzstbj@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 15, 2011
• First Posted: December 21, 2011
• Study Start: January 1, 2012
• Primary Completion: June 1, 2012
• Study Completion: January 1, 2013
• Last Updated: December 21, 2011

Record last verified: 2011-12

Locations

CN (1)