| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN22669537 |
| Date ISRCTN assigned | 01/07/2001 |
| Local reference number(s) | ukCAP |
| Public title | A multi-centre double blind randomised controlled trial of aspirin and/or folate supplementation for the prevention of recurrent colorectal adenomas |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Colon, rectum |
| 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. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | 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) |
| Countries of trial | United Kingdom, Denmark |
| Participants - 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 |
| Participants - 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 |
| Patient information material |
|
| Anticipated start date | 01/12/1997 |
| Anticipated end date | 01/07/2005 |
| Status of trial | Completed |
| Target number of participants | 1,000 |
| Interventions | 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 |
| Primary outcome measure(s) | Percentage of patients who developed one or more recurrent colorectal adenomas or cancers |
| Secondary outcome measure(s) | 1. Number of recurrent adenomas detected during follow-up
2. Percentage of patients who developed advanced colorectal neoplasia during follow-up |
| Sources of funding | Cancer Research UK (UK) |
| Sponsor name | Cancer Research UK |
| Sponsor details | PO Box 123
Lincoln's Inn Fields
London
United Kingdom
WC2A 3PX |
| Sponsor telephone | +44 (0)20 7317 5186 |
| Sponsor fax | +44 (0)20 7487 4302 |
| Sponsor email | kate.law@cancer.org.uk |
| Sponsor website | http://www.cancer.org.uk |
| Contact name | Prof Richard Logan |
| Contact details | School of Community Health Sciences
Medical School
University of Nottingham
Nottingham
United Kingdom
NG7 2UH |
| Contact telephone | +44 (0)115 823 0452 |
| Contact fax | +44 (0)115 823 0464 |
| Contact email | Richard.Logan@nottingham.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN22669537 |
| Date last extracted from ISRCTN register | 17/04/2008 |
