Aspirin and/or Folic Acid in Preventing Recurrent Colorectal Polyps
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00033319|
Recruitment Status : Unknown
Verified December 2002 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : July 1, 2003
Last Update Posted : September 17, 2013
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of aspirin and/or folic acid may be effective in preventing recurrent polyps in patients who have had polyps removed previously.
PURPOSE: Randomized clinical trial to determine the effectiveness of aspirin and/or folic acid in preventing the recurrence of colorectal polyps.
|Condition or disease||Intervention/treatment|
|Colorectal Cancer||Dietary Supplement: folic acid Drug: acetylsalicylic acid|
- Determine whether aspirin and/or folic acid prevents recurrence of colorectal adenomas in patients who have had colorectal adenomas removed.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 4 treatment arms.
- Arm I: Patients receive oral aspirin and oral folic acid daily.
- Arm II: Patients receive oral aspirin and oral placebo daily.
- Arm III: Patients receive oral placebo and oral folic acid daily.
- Arm IV: Patients receive 2 oral placebos daily. In all arms, treatment continues for 3 years in the absence of unacceptable toxicity.
After completion of the 3-year intervention, all patients undergo a surveillance colonoscopy.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 1,300 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||UKCAP Trial: A Multi-Center Double Blind Randomised Controlled Trial Of Aspirin And/Or Folate Supplementation For the Prevention Of Recurrent Colorectal Adenomas|
|Study Start Date :||May 1997|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00033319
|Antrim, England, United Kingdom, BR41 2RL|
|City Hospital - Birmingham|
|Birmingham, England, United Kingdom, B18 7QH|
|Birmingham Heartlands and Solihull NHS Trust (Teaching)|
|Birmingham, England, United Kingdom, B9 5SS|
|Bristol, England, United Kingdom, BS10 5NB|
|Bristol, England, United Kingdom, BS16 1LE|
|Bristol Royal Infirmary|
|Bristol, England, United Kingdom, BS2 8HW|
|Derby City General Hospital|
|Derby, England, United Kingdom, DE22 3NE|
|Dudley, England, United Kingdom, DY8 5QX|
|Leicester, England, United Kingdom, LE3 9QP|
|Royal Liverpool and Broadgreen Hospitals|
|Liverpool, England, United Kingdom, L7 8XP|
|Manchester Royal Infirmary|
|Manchester, England, United Kingdom, M13 9WL|
|Manchester, England, United Kingdom, M23 9LJ|
|Trafford General Hospital|
|Manchester, England, United Kingdom, M31 3SL|
|Southport and Formby District General Hospital|
|Merseyside, England, United Kingdom, PR8 6NJ|
|Merthyr Tydfil Hospital|
|Merthyr, England, United Kingdom|
|Nottingham City Hospital NHS Trust|
|Nottingham, England, United Kingdom, NG5 1PB|
|Queen's Medical Centre|
|Nottingham, England, United Kingdom, NG7 2UH|
|Prescot Merseyside, England, United Kingdom, L35 5DR|
|Salford Royal Hospitals NHS Trust|
|Salford, England, United Kingdom, M6 8HD|
|Sheffield Teaching Hospitals|
|Sheffield, England, United Kingdom, S1O 2JF|
|Northern General Hospital|
|Sheffield, England, United Kingdom, S5 7AU|
|Solihull, England, United Kingdom, B91 3AH|
|Royal Victoria Hospital|
|Belfast, Northern Ireland, United Kingdom, BT12 6BA|
|Newtownabbey, Northern Ireland, United Kingdom|
|Princess of Wales Hospital|
|Bridgend, Wales, United Kingdom, CF31 1JP|
|University of Wales College of Medicine|
|Cardiff, Wales, United Kingdom, CF14 4XN|
|Selly Oak Hospital|
|Birmingham, United Kingdom, B29 6JD|
|East Glamorgan Hospital|
|Lhantrisant, United Kingdom, CF72 8XR|
|North Manchester Healthcare NHS Trust|
|Manchester, United Kingdom, M8 6RB|
|Royal Gwent Hospital|
|Newport Gwent, United Kingdom, NP9 2UB|
|King's Mills Hospital|
|Nottinghamshire, United Kingdom, NG17 4JL|
|Rotherham District General Hospital-NHS Trust|
|Rotherham, United Kingdom, S60 2UD|
|Study Chair:||Richard Logan, MD||Queen's Medical Centre|