Aspirin and/or Folic Acid in Preventing Recurrent Colorectal Polyps

Overview

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.

Full Title of Study: “UKCAP Trial: A Multi-Center Double Blind Randomised Controlled Trial Of Aspirin And/Or Folate Supplementation For the Prevention Of Recurrent Colorectal Adenomas”

Study Type

  • Study Type: Interventional
  • Study Design
    • Primary Purpose: Prevention

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.

Interventions

  • Dietary Supplement: folic acid
  • Drug: acetylsalicylic acid

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Queen’s Medical Center
  • Overall Official(s)
    • Richard Logan, MD, Study Chair, Queen’s Medical Center

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