Carcinoma, Squamous CellPhase 3CREATNCT01496521
Chemoprevention of Esophageal Squamous Cell Carcinoma (ESCC) With Aspirin and Tea Polyphenols
A Phase 3 study testing Aspirin and Tea Polyphenols in people with Carcinoma, Squamous Cell, run by Beijing Friendship Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Carcinoma, Squamous Cell
- What is being tested?
- Aspirin and Tea Polyphenols
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- Jan 2012to Jan 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Friendship Hospital Capital Medical University
Beijing, 100050
About this study
Official title: 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.
- Conditions
- Carcinoma, Squamous Cell
- Being tested
- Aspirin, Tea Polyphenols
- Keywords
- Aspirin, polyphenols, Chemoprevention
- Medical subject headings
- Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
100mg qd for 6 months.
Tea PolyphenolsDietary supplement
300mg bid for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Aspirin | Experimental | Not described Receives: Drug: Aspirin |
| Tea Polyphenols | Experimental | Not described Receives: Dietary Supplement: Tea Polyphenols |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence of high grade dysplasia and invasive ESCC
Measured: at six months
Secondary outcomes (3)
the mortality of the participants
Measured: The first interval will be at six months and the second at 3 or 5 years later.
Number of participants with adverse events.
Measured: 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
Measured: at 3 or 5 years later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionJun 2012 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Squamous CellStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shu-Tian Zhang, Beijing Friendship Hospital
- Investigators
- Shu-Tian Zhang, MD, Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01496521
- Sponsor's protocol ID
- CREAT
- Acronym
- CREAT
- Status last verified
- Dec 2011
- First submitted
- 15 Dec 2011
- Last updated
- 21 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemoprevention of Esophageal Squamous Cell Carcinoma With Aspirin and Tea Polyphenols: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01496521
- Acronym / sponsor ID
- CREAT / CREAT
- Conditions
- Carcinoma, Squamous Cell
- Keywords
- Aspirin, polyphenols, Chemoprevention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 21 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aspirin | Experimental | Drug: Aspirin |
| Tea Polyphenols | Experimental | Dietary Supplement: Tea Polyphenols |
| Control | No intervention | – |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspirin100mg qd for 6 months. | Drug | Aspirin |
| Tea Polyphenols300mg bid for 6 months. | Dietary supplement | Tea Polyphenols |
Primary outcome
occurrence of high grade dysplasia and invasive ESCC
Time frame: at six months
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shu-Tian Zhang, MD principal investigator
Beijing Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aspirin and Tea Polyphenols in people with Carcinoma, Squamous Cell, run by Beijing Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shu-Tian Zhang, MD (+86 010 63138067, drzstbj@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
occurrence of high grade dysplasia and invasive ESCC (time frame: at six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2011.