Back to resultsAspirin and/or Folic Acid in Preventing Recurrent Colorectal Polyps
Primary Purpose
Colorectal Cancer
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
folic acid
acetylsalicylic acid
Sponsored by
About this trial
This is an interventional prevention trial for Colorectal Cancer focused on measuring colon cancer, rectal cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed colorectal adenoma removed within the past 6 months Greater than 0.5 cm after fixation or greater than 0.7 cm at time of removal OR Any size with a history of prior colorectal adenoma removal(s) Removed via colonoscopy, flexi-sigmoidoscopy (provided barium enema has been performed), or transanal endoscopic microsurgery Removal must be considered complete with follow-up to be done within 6 months No prior resection of large bowel (e.g., hemi-colectomy or greater, anterior resection, or subtotal colectomy) PATIENT CHARACTERISTICS: Age: 75 and under Performance status: Not specified Life expectancy: Not specified Hematopoietic: No active bleeding disorders Hepatic: Not specified Renal: Not specified Cardiovascular: No unstable heart conditions Pulmonary: No unstable asthma Other: Not pregnant and no potential to become pregnant within the next 3 years No unstable diabetes No active upper gastrointestinal ulceration No known aspirin intolerance or sensitivity No other serious medical conditions that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics Other: No other concurrent folic acid No concurrent anticoagulants No other prior or concurrent non-steroidal anti-inflammatory drugs, prescribed or self-medicated (more than 3 tablets per week)
Sites / Locations
- Antrim Hospital
- City Hospital - Birmingham
- Birmingham Heartlands and Solihull NHS Trust (Teaching)
- Southmead Hospital
- Frenchay Hospital
- Bristol Royal Infirmary
- Derby City General Hospital
- Wordsley Hospital
- Glenfield Hospital
- Royal Liverpool and Broadgreen Hospitals
- Manchester Royal Infirmary
- Wythenshawe Hospital
- Trafford General Hospital
- Southport and Formby District General Hospital
- Merthyr Tydfil Hospital
- Nottingham City Hospital NHS Trust
- Queen's Medical Centre
- Whiston Hospital
- Salford Royal Hospitals NHS Trust
- Sheffield Teaching Hospitals
- Northern General Hospital
- Solihull Hospital
- Royal Victoria Hospital
- Whiteabbey Hospital
- Princess of Wales Hospital
- University of Wales College of Medicine
- Selly Oak Hospital
- East Glamorgan Hospital
- North Manchester Healthcare NHS Trust
- Royal Gwent Hospital
- King's Mills Hospital
- Rotherham District General Hospital-NHS Trust
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00033319
First Posted
April 9, 2002
Last Updated
September 16, 2013
Sponsor
Queen's Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00033319
Brief Title
Aspirin and/or Folic Acid in Preventing Recurrent Colorectal Polyps
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 Type
Interventional
2. Study Status
Record Verification Date
December 2002
Overall Recruitment Status
Unknown status
Study Start Date
May 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Queen's Medical Center
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
colon cancer, rectal cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
8. Arms, Groups, and Interventions
Intervention Type
Dietary Supplement
Intervention Name(s)
folic acid
Intervention Type
Drug
Intervention Name(s)
acetylsalicylic acid
10. Eligibility
Sex
All
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed colorectal adenoma removed within the past 6 months
Greater than 0.5 cm after fixation or greater than 0.7 cm at time of removal
OR
Any size with a history of prior colorectal adenoma removal(s)
Removed via colonoscopy, flexi-sigmoidoscopy (provided barium enema has been performed), or transanal endoscopic microsurgery
Removal must be considered complete with follow-up to be done within 6 months
No prior resection of large bowel (e.g., hemi-colectomy or greater, anterior resection, or subtotal colectomy)
PATIENT CHARACTERISTICS:
Age:
75 and under
Performance status:
Not specified
Life expectancy:
Not specified
Hematopoietic:
No active bleeding disorders
Hepatic:
Not specified
Renal:
Not specified
Cardiovascular:
No unstable heart conditions
Pulmonary:
No unstable asthma
Other:
Not pregnant and no potential to become pregnant within the next 3 years
No unstable diabetes
No active upper gastrointestinal ulceration
No known aspirin intolerance or sensitivity
No other serious medical conditions that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Not specified
Chemotherapy:
Not specified
Endocrine therapy:
Not specified
Radiotherapy:
Not specified
Surgery:
See Disease Characteristics
Other:
No other concurrent folic acid
No concurrent anticoagulants
No other prior or concurrent non-steroidal anti-inflammatory drugs, prescribed or self-medicated (more than 3 tablets per week)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Logan, MD
Organizational Affiliation
Queen's Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Antrim Hospital
City
Antrim
State/Province
England
ZIP/Postal Code
BR41 2RL
Country
United Kingdom
Facility Name
City Hospital - Birmingham
City
Birmingham
State/Province
England
ZIP/Postal Code
B18 7QH
Country
United Kingdom
Facility Name
Birmingham Heartlands and Solihull NHS Trust (Teaching)
City
Birmingham
State/Province
England
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Southmead Hospital
City
Bristol
State/Province
England
ZIP/Postal Code
BS10 5NB
Country
United Kingdom
Facility Name
Frenchay Hospital
City
Bristol
State/Province
England
ZIP/Postal Code
BS16 1LE
Country
United Kingdom
Facility Name
Bristol Royal Infirmary
City
Bristol
State/Province
England
ZIP/Postal Code
BS2 8HW
Country
United Kingdom
Facility Name
Derby City General Hospital
City
Derby
State/Province
England
ZIP/Postal Code
DE22 3NE
Country
United Kingdom
Facility Name
Wordsley Hospital
City
Dudley
State/Province
England
ZIP/Postal Code
DY8 5QX
Country
United Kingdom
Facility Name
Glenfield Hospital
City
Leicester
State/Province
England
ZIP/Postal Code
LE3 9QP
Country
United Kingdom
Facility Name
Royal Liverpool and Broadgreen Hospitals
City
Liverpool
State/Province
England
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
Manchester Royal Infirmary
City
Manchester
State/Province
England
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
Wythenshawe Hospital
City
Manchester
State/Province
England
ZIP/Postal Code
M23 9LJ
Country
United Kingdom
Facility Name
Trafford General Hospital
City
Manchester
State/Province
England
ZIP/Postal Code
M31 3SL
Country
United Kingdom
Facility Name
Southport and Formby District General Hospital
City
Merseyside
State/Province
England
ZIP/Postal Code
PR8 6NJ
Country
United Kingdom
Facility Name
Merthyr Tydfil Hospital
City
Merthyr
State/Province
England
Country
United Kingdom
Facility Name
Nottingham City Hospital NHS Trust
City
Nottingham
State/Province
England
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Queen's Medical Centre
City
Nottingham
State/Province
England
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Whiston Hospital
City
Prescot Merseyside
State/Province
England
ZIP/Postal Code
L35 5DR
Country
United Kingdom
Facility Name
Salford Royal Hospitals NHS Trust
City
Salford
State/Province
England
ZIP/Postal Code
M6 8HD
Country
United Kingdom
Facility Name
Sheffield Teaching Hospitals
City
Sheffield
State/Province
England
ZIP/Postal Code
S1O 2JF
Country
United Kingdom
Facility Name
Northern General Hospital
City
Sheffield
State/Province
England
ZIP/Postal Code
S5 7AU
Country
United Kingdom
Facility Name
Solihull Hospital
City
Solihull
State/Province
England
ZIP/Postal Code
B91 3AH
Country
United Kingdom
Facility Name
Royal Victoria Hospital
City
Belfast
State/Province
Northern Ireland
ZIP/Postal Code
BT12 6BA
Country
United Kingdom
Facility Name
Whiteabbey Hospital
City
Newtownabbey
State/Province
Northern Ireland
Country
United Kingdom
Facility Name
Princess of Wales Hospital
City
Bridgend
State/Province
Wales
ZIP/Postal Code
CF31 1JP
Country
United Kingdom
Facility Name
University of Wales College of Medicine
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 4XN
Country
United Kingdom
Facility Name
Selly Oak Hospital
City
Birmingham
ZIP/Postal Code
B29 6JD
Country
United Kingdom
Facility Name
East Glamorgan Hospital
City
Lhantrisant
ZIP/Postal Code
CF72 8XR
Country
United Kingdom
Facility Name
North Manchester Healthcare NHS Trust
City
Manchester
ZIP/Postal Code
M8 6RB
Country
United Kingdom
Facility Name
Royal Gwent Hospital
City
Newport Gwent
ZIP/Postal Code
NP9 2UB
Country
United Kingdom
Facility Name
King's Mills Hospital
City
Nottinghamshire
ZIP/Postal Code
NG17 4JL
Country
United Kingdom
Facility Name
Rotherham District General Hospital-NHS Trust
City
Rotherham
ZIP/Postal Code
S60 2UD
Country
United Kingdom
12. IPD Sharing Statement
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Aspirin and/or Folic Acid in Preventing Recurrent Colorectal Polyps
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