A multi-centre double blind randomised controlled trial of aspirin and/or folate supplementation for the prevention of recurrent colorectal adenomas

ISRCTN	ISRCTN22669537
DOI	https://doi.org/10.1186/ISRCTN22669537
Secondary identifying numbers	ukCAP

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Richard Logan
Scientific

School of Community Health Sciences
Medical School
University of Nottingham
Nottingham
NG7 2UH
United Kingdom

Phone	+44 (0)115 823 0452
Email	Richard.Logan@nottingham.ac.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Prevention
Scientific title	A multi-centre double blind randomised controlled trial of aspirin and/or folate supplementation for the prevention of recurrent colorectal adenoma
Study objectives	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(s)	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)
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	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 study start date	01/12/1997
Completion date	01/07/2005

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	1,000
Key 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
Key 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
Date of first enrolment	01/12/1997
Date of final enrolment	01/07/2005

School of Community Health Sciences

Nottingham
NG7 2UH
United Kingdom

Cancer Research UK (CRUK) (UK)
Charity

PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom

Charity

Cancer Research UK (CRUK) (UK)
Private sector organisation / Other non-profit organizations

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Plain English results				No	Yes
Results article	results	01/01/2008		Yes	No

18/10/2018: Cancer Research UK lay results summary link added to Results (plain English)