Aspirin and/or Folic Acid in Preventing Recurrent Colorectal Polyps
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|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
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 or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Dietary Supplement: folic acid Drug: acetylsalicylic acid||Not Applicable|
- 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 (Clinical Trial)|
|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|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00033319
|Study Chair:||Richard Logan, MD||Queen's Medical Centre|