Aspirin and/or Folic Acid in Preventing Recurrent Colorectal Polyps

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2002 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00033319
First received: April 9, 2002
Last updated: September 16, 2013
Last verified: December 2002
  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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00033319

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
Sponsors and Collaborators
Queen's Medical Centre
Investigators
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: September 16, 2013
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 July 29, 2014