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Aspirin and/or Folic Acid in Preventing Recurrent Colorectal Polyps

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00033319
Recruitment Status : Unknown
Verified December 2002 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : July 1, 2003
Last Update Posted : September 17, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE April 9, 2002
First Posted Date  ICMJE July 1, 2003
Last Update Posted Date September 17, 2013
Study Start Date  ICMJE May 1997
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aspirin and/or Folic Acid in Preventing Recurrent Colorectal Polyps
Official Title  ICMJE UKCAP Trial: A Multi-Center Double Blind Randomised Controlled Trial Of Aspirin And/Or Folate Supplementation For the Prevention Of Recurrent Colorectal Adenomas
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Primary Purpose: Prevention
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Dietary Supplement: folic acid
  • Drug: acetylsalicylic acid
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00033319
Other Study ID Numbers  ICMJE CDR0000069273
QMC-UKCAP
EU-20045
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Queen's Medical Centre
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Richard Logan, MD Queen's Medical Centre
PRS Account National Cancer Institute (NCI)
Verification Date December 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP