Aspirin and/or Folic Acid in Preventing Recurrent Colorectal Polyps
- Conditions
- Colorectal Cancer
- Registration Number
- NCT00033319
- Lead Sponsor
- Queen's Medical Center
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
* 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (32)
Antrim Hospital
🇬🇧Antrim, England, United Kingdom
Glenfield Hospital
🇬🇧Leicester, England, United Kingdom
Wythenshawe Hospital
🇬🇧Manchester, England, United Kingdom
Merthyr Tydfil Hospital
🇬🇧Merthyr, England, United Kingdom
Trafford General Hospital
🇬🇧Manchester, England, United Kingdom
Southmead Hospital
🇬🇧Bristol, England, United Kingdom
Frenchay Hospital
🇬🇧Bristol, England, United Kingdom
Royal Liverpool and Broadgreen Hospitals
🇬🇧Liverpool, England, United Kingdom
Birmingham Heartlands and Solihull NHS Trust (Teaching)
🇬🇧Birmingham, England, United Kingdom
Southport and Formby District General Hospital
🇬🇧Merseyside, England, United Kingdom
Manchester Royal Infirmary
🇬🇧Manchester, England, United Kingdom
Nottingham City Hospital NHS Trust
🇬🇧Nottingham, England, United Kingdom
Derby City General Hospital
🇬🇧Derby, England, United Kingdom
Wordsley Hospital
🇬🇧Dudley, England, United Kingdom
Solihull Hospital
🇬🇧Solihull, England, United Kingdom
Selly Oak Hospital
🇬🇧Birmingham, United Kingdom
Princess of Wales Hospital
🇬🇧Bridgend, Wales, United Kingdom
Bristol Royal Infirmary
🇬🇧Bristol, England, United Kingdom
Northern General Hospital
🇬🇧Sheffield, England, United Kingdom
Sheffield Teaching Hospitals
🇬🇧Sheffield, England, United Kingdom
Salford Royal Hospitals NHS Trust
🇬🇧Salford, England, United Kingdom
Queen's Medical Centre
🇬🇧Nottingham, England, United Kingdom
East Glamorgan Hospital
🇬🇧Lhantrisant, United Kingdom
Royal Gwent Hospital
🇬🇧Newport Gwent, United Kingdom
University of Wales College of Medicine
🇬🇧Cardiff, Wales, United Kingdom
Royal Victoria Hospital
🇬🇧Belfast, Northern Ireland, United Kingdom
King's Mills Hospital
🇬🇧Nottinghamshire, United Kingdom
Whiteabbey Hospital
🇬🇧Newtownabbey, Northern Ireland, United Kingdom
North Manchester Healthcare NHS Trust
🇬🇧Manchester, United Kingdom
Whiston Hospital
🇬🇧Prescot Merseyside, England, United Kingdom
City Hospital - Birmingham
🇬🇧Birmingham, England, United Kingdom
Rotherham District General Hospital-NHS Trust
🇬🇧Rotherham, United Kingdom