NCT00033319

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: —
• Sponsor: Queen's Medical Center · Academic / Other
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	folic acid
DRUG	acetylsalicylic acid

Timeline

• Start date: 1997-05-01
• First posted: 2003-07-01
• Last updated: 2013-09-17

Locations

32 sites across 1 country: United Kingdom