Aspirin and/or Folic Acid in Preventing Recurrent Colorectal Polyps

UKCAP Trial: A Multi-Center Double Blind Randomised Controlled Trial Of Aspirin And/Or Folate Supplementation For the Prevention Of Recurrent Colorectal Adenomas

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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: acetylsalicylic acid; Dietary supplement: folic acid

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 75 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION

Collaborators and Investigators

• Sponsor: Queen's Medical Center
• Investigators: Study Chair: Richard Logan, MD, Queen's Medical Center

Study record dates

Study Major Dates

• Study Start: May 1, 1997

Study Registration Dates

• First Submitted: April 9, 2002
• First Submitted That Met QC Criteria: June 30, 2003
• First Posted (ESTIMATE): July 1, 2003

Study Record Updates

• Last Update Posted (ESTIMATE): September 17, 2013
• Last Update Submitted That Met QC Criteria: September 16, 2013
• Last Verified: December 1, 2002

More Information

Terms related to this study

• Keywords: rectal cancer; colon cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Micronutrients; Vitamins; Vitamin B Complex; Hematinics; Aspirin; Folic Acid
• Other Study ID Numbers: CDR0000069273; QMC-UKCAP; EU-20045