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ISRCTN
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ISRCTN22669537
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ClinicalTrials.gov identifier
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Public title
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A multi-centre double blind randomised controlled trial of aspirin and/or folate supplementation for the prevention of recurrent colorectal adenomas
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Scientific title
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Acronym
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N/A
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Serial number at source
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ukCAP
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Study hypothesis
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To determine whether aspirin (300 mg/day) and/or folic acid (0.5 mg/day) could be used to prevent further colorectal adenomas in the high risk group of patients with previous colorectal adenomas removed by colonoscopy.
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Ethics approval
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1. LREC approval (Nottingham): gained on 19/11/98 (ref: EC98/203)
2. MREC approval (Trent): gained on 02/12/03 (ref: 98/4/055)
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Study design
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Randomised controlled trial
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Countries of recruitment
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Denmark, United Kingdom
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Disease/condition/study domain
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Colon, rectum
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Participants - inclusion criteria
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Eligible patients who have had:
1. Removal of adenomas greater than 0.5 cm after fixation or adenomas greater than 0.7 cm at the time of removal, within the last six months
2. A previous history of removal of such adenomas and have had adenoma of any size removed in the six months prior to recruitment These adenomas will be histologically confirmed and removed by either colonoscopy, flexi-sigmoidoscopy or via Transanal Endoscopic Microsurgery (TEMS) procedure
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Participants - exclusion criteria
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1. Over 75 years at time of recruitment
2. Serious medical conditions likely to preclude successful completion of the trial
3. Existing use of prescribed Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) including aspirin
4. Known aspirin intolerance or sensitivity
5. Active bleeding disorders or upper Gastrointestinal (GI) ulceration, including use of anticoagulants
6. Previous resection of the large bowel
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Anticipated start date
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01/12/1997
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Anticipated end date
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01/07/2005
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Status of trial
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Completed
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Patient information material
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Target number of participants
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1,000
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Interventions
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Arm A: Aspirin and Folate
Arm B: Aspirin and Placebo Folate
Arm C: Placebo Aspirin and Folate
Arm D: Placebo Aspirin and Placebo Folate Aspirin 300 mg E.C/day Folate 500 ug/day
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Primary outcome measure(s)
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Percentage of patients who developed one or more recurrent colorectal adenomas or cancers
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Secondary outcome measure(s)
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1. Number of recurrent adenomas detected during follow-up
2. Percentage of patients who developed advanced colorectal neoplasia during follow-up
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Sources of funding
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Cancer Research UK (UK)
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Trial website
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Publications
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Contact name
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Prof
Richard
Logan
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Address
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School of Community Health Sciences
Medical School
University of Nottingham
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City/town
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Nottingham
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Zip/Postcode
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NG7 2UH
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Country
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United Kingdom
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Tel
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+44 (0)115 823 0452
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Fax
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+44 (0)115 823 0464
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Email
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Richard.Logan@nottingham.ac.uk
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Sponsor
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Cancer Research UK (CRUK) (UK)
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Address
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PO Box 123
Lincoln's Inn Fields
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City/town
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London
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Zip/Postcode
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WC2A 3PX
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Country
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United Kingdom
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Tel
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+44 (0)20 7317 5186
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Fax
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+44 (0)20 7487 4302
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Email
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kate.law@cancer.org.uk
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Sponsor website:
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http://www.cancer.org.uk
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Date applied
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01/07/2001
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Last edited
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05/08/2008
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Date ISRCTN assigned
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01/07/2001
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