Aspirin and/or Folic Acid in Preventing Recurrent Colorectal Polyps

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Queen's Medical Centre
• Treatments: Aspirin; Folic Acid; Vitamin B Complex

Criteria

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)