Aspirin and/or Folic Acid in Preventing Recurrent Colorectal Polyps

Colorectal Cancer 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

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Primary Purpose: Prevention

Related Conditions & MeSH terms

• Colorectal Cancer

• NCT number: NCT00033319
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1997