Contact information
Type
Scientific
Primary contact
Prof Richard Logan
ORCID ID
Contact details
School of Community Health Sciences
Medical School
University of Nottingham
Nottingham
NG7 2UH
United Kingdom
+44 (0)115 823 0452
Richard.Logan@nottingham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ukCAP
Study information
Scientific title
A multi-centre double blind randomised controlled trial of aspirin and/or folate supplementation for the prevention of recurrent colorectal adenoma
Acronym
Study hypothesis
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.
Ethics approval
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)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Condition
Recurrent colorectal adenomas
Intervention
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
Intervention type
Drug
Phase
Not Applicable
Drug names
Aspirin, folate
Primary outcome measure
Percentage of patients who developed one or more recurrent colorectal adenomas or cancers
Secondary outcome measures
1. Number of recurrent adenomas detected during follow-up
2. Percentage of patients who developed advanced colorectal neoplasia during follow-up
Overall trial start date
01/12/1997
Overall trial end date
01/07/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1,000
Participant exclusion criteria
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
Recruitment start date
01/12/1997
Recruitment end date
01/07/2005
Locations
Countries of recruitment
Denmark, United Kingdom
Trial participating centre
School of Community Health Sciences
Nottingham
NG7 2UH
United Kingdom
Sponsor information
Organisation
Cancer Research UK (CRUK) (UK)
Sponsor details
PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
+44 (0)207 317 5186
kate.law@cancer.org.uk
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK (CRUK) (UK)
Alternative name(s)
Funding Body Type
unknown
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18022173
Publication citations
-
Results
Logan RF, Grainge MJ, Shepherd VC, Armitage NC, Muir KR, , Aspirin and folic acid for the prevention of recurrent colorectal adenomas., Gastroenterology, 2008, 134, 1, 29-38, doi: 10.1053/j.gastro.2007.10.014.