Aspirin and/or Folic Acid in Preventing Recurrent Colorectal Polyps
Recruitment status was Active, not recruiting
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Purpose
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 | Intervention |
|---|---|
|
Colorectal Cancer |
Dietary Supplement: folic acid Drug: acetylsalicylic acid |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Prevention |
| 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 |
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.
Eligibility| Ages Eligible for Study: | up to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations| United Kingdom | |
| Antrim Hospital | |
| Antrim, England, United Kingdom, BR41 2RL | |
| Birmingham Heartlands and Solihull NHS Trust (Teaching) | |
| Birmingham, England, United Kingdom, B9 5SS | |
| City Hospital - Birmingham | |
| Birmingham, England, United Kingdom, B18 7QH | |
| Bristol Royal Infirmary | |
| Bristol, England, United Kingdom, BS2 8HW | |
| Southmead Hospital | |
| Bristol, England, United Kingdom, BS10 5NB | |
| Frenchay Hospital | |
| Bristol, England, United Kingdom, BS16 1LE | |
| Derby City General Hospital | |
| Derby, England, United Kingdom, DE22 3NE | |
| Wordsley Hospital | |
| Dudley, England, United Kingdom, DY8 5QX | |
| Glenfield Hospital | |
| Leicester, England, United Kingdom, LE3 9QP | |
| Royal Liverpool and Broadgreen Hospitals | |
| Liverpool, England, United Kingdom, L7 8XP | |
| Wythenshawe Hospital | |
| Manchester, England, United Kingdom, M23 9LJ | |
| Manchester Royal Infirmary | |
| Manchester, England, United Kingdom, M13 9WL | |
| 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 | |
| Whiston Hospital | |
| 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 Hospital | |
| Solihull, England, United Kingdom, B91 3AH | |
| Royal Victoria Hospital | |
| Belfast, Northern Ireland, United Kingdom, BT12 6BA | |
| Whiteabbey Hospital | |
| 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 |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00033319 History of Changes |
| Other Study ID Numbers: | CDR0000069273, QMC-UKCAP, EU-20045 |
| Study First Received: | April 9, 2002 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
colon cancer rectal cancer |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Aspirin Folic Acid Vitamin B Complex Anti-Inflammatory Agents, Non-Steroidal |
Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Hematologic Agents Platelet Aggregation Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013