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Aspirin and/or Folic Acid in Preventing Recurrent Colorectal Polyps
This study is ongoing, but not recruiting participants.
Sponsored by: Queen's Medical Centre
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00033319
  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
Drug: acetylsalicylic acid
Drug: folic acid

MedlinePlus related topics: Cancer Colorectal Cancer
Drug Information available for: Folic acid Acetylsalicylic acid
U.S. FDA Resources
Study Type: Interventional
Study Design: 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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: May 1997
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.

  Eligibility

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00033319

Locations
United Kingdom
East Glamorgan Hospital
Lhantrisant, United Kingdom, CF72 8XR
King's Mills Hospital
Nottinghamshire, United Kingdom, NG17 4JL
North Manchester Healthcare NHS Trust
Manchester, United Kingdom, M8 6RB
Selly Oak Hospital
Birmingham, United Kingdom, B29 6JD
Royal Gwent Hospital
Newport Gwent, United Kingdom, NP9 2UB
Rotherham District General Hospital-NHS Trust
Rotherham, United Kingdom, S60 2UD
United Kingdom, England
Antrim Hospital
Antrim, England, United Kingdom, BR41 2RL
Birmingham Heartlands and Solihull NHS Trust (Teaching)
Birmingham, England, United Kingdom, B9 5SS
Northern General Hospital
Sheffield, England, United Kingdom, S5 7AU
City Hospital - Birmingham
Birmingham, England, United Kingdom, B18 7QH
Derby City General Hospital
Derby, England, United Kingdom, DE22 3NE
Frenchay Hospital
Bristol, England, United Kingdom, BS16 1LE
Glenfield Hospital
Leicester, England, United Kingdom, LE3 9QP
Manchester Royal Infirmary
Manchester, England, United Kingdom, M13 9WL
Merthyr Tydfil Hospital
Merthyr, England, United Kingdom
Bristol Royal Infirmary
Bristol, England, United Kingdom, BS2 8HW
Nottingham City Hospital NHS Trust
Nottingham, England, United Kingdom, NG5 1PB
Queen's Medical Centre
Nottingham, England, United Kingdom, NG7 2UH
Royal Liverpool and Broadgreen Hospitals
Liverpool, England, United Kingdom, L7 8XP
Salford Royal Hospitals NHS Trust
Salford, England, United Kingdom, M6 8HD
Southport and Formby District General Hospital
Merseyside, England, United Kingdom, PR8 6NJ
Solihull Hospital
Solihull, England, United Kingdom, B91 3AH
Southmead Hospital
Bristol, England, United Kingdom, BS10 5NB
Sheffield Teaching Hospitals
Sheffield, England, United Kingdom, S1O 2JF
Trafford General Hospital
Manchester, England, United Kingdom, M31 3SL
Whiston Hospital
Prescot Merseyside, England, United Kingdom, L35 5DR
Wordsley Hospital
Dudley, England, United Kingdom, DY8 5QX
Wythenshawe Hospital
Manchester, England, United Kingdom, M23 9LJ
United Kingdom, Northern Ireland
Royal Victoria Hospital
Belfast, Northern Ireland, United Kingdom, BT12 6BA
Whiteabbey Hospital
Newtownabbey, Northern Ireland, United Kingdom
United Kingdom, Wales
Princess of Wales Hospital
Bridgend, Wales, United Kingdom, CF31 1JP
University of Wales College of Medicine
Cardiff, Wales, United Kingdom, CF14 4XN
Sponsors and Collaborators
Queen's Medical Centre
Investigators
Study Chair: Richard Logan, MD Queen's Medical Centre
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000069273, QMC-UKCAP, EU-20045
Study First Received: April 9, 2002
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00033319  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
colon cancer
rectal cancer

Study placed in the following topic categories:
Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Polyps
Intestinal Diseases
Rectal Diseases
Recurrence
Intestinal Neoplasms
Rectal neoplasm
Folic Acid
Digestive System Diseases
Aspirin
Gastrointestinal Neoplasms
Rectal cancer
Adenoma
Colorectal Neoplasms

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hematologic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Neoplasms by Site
Sensory System Agents
Therapeutic Uses
Vitamins
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Micronutrients
Vitamin B Complex
Hematinics
Growth Substances
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Cardiovascular Agents
Pharmacologic Actions
Neoplasms
Analgesics, Non-Narcotic
Platelet Aggregation Inhibitors
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009