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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00033319
• Other study ID #: CDR0000069273
• Secondary ID: QMC-UKCAPEU-2004
• Status: Active, not recruiting
• Phase: N/A
• First received: April 9, 2002
• Last updated: September 16, 2013
• Start date: May 1997

Study information

• Verified date: December 2002
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 75 Years

Eligibility

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)

Study Design

Primary Purpose: Prevention

Related Conditions & MeSH terms

• Colorectal Cancer

Intervention

Dietary Supplement:
• folic acid

Drug:
• acetylsalicylic acid

Locations

Country	Name	City	State
United Kingdom	Antrim Hospital	Antrim	England
United Kingdom	Royal Victoria Hospital	Belfast	Northern Ireland
United Kingdom	Birmingham Heartlands and Solihull NHS Trust (Teaching)	Birmingham	England
United Kingdom	City Hospital - Birmingham	Birmingham	England
United Kingdom	Selly Oak Hospital	Birmingham
United Kingdom	Princess of Wales Hospital	Bridgend	Wales
United Kingdom	Bristol Royal Infirmary	Bristol	England
United Kingdom	Frenchay Hospital	Bristol	England
United Kingdom	Southmead Hospital	Bristol	England
United Kingdom	University of Wales College of Medicine	Cardiff	Wales
United Kingdom	Derby City General Hospital	Derby	England
United Kingdom	Wordsley Hospital	Dudley	England
United Kingdom	Glenfield Hospital	Leicester	England
United Kingdom	East Glamorgan Hospital	Lhantrisant
United Kingdom	Royal Liverpool and Broadgreen Hospitals	Liverpool	England
United Kingdom	Manchester Royal Infirmary	Manchester	England
United Kingdom	North Manchester Healthcare NHS Trust	Manchester
United Kingdom	Trafford General Hospital	Manchester	England
United Kingdom	Wythenshawe Hospital	Manchester	England
United Kingdom	Southport and Formby District General Hospital	Merseyside	England
United Kingdom	Merthyr Tydfil Hospital	Merthyr	England
United Kingdom	Royal Gwent Hospital	Newport Gwent
United Kingdom	Whiteabbey Hospital	Newtownabbey	Northern Ireland
United Kingdom	Nottingham City Hospital NHS Trust	Nottingham	England
United Kingdom	Queen's Medical Centre	Nottingham	England
United Kingdom	King's Mills Hospital	Nottinghamshire
United Kingdom	Whiston Hospital	Prescot Merseyside	England
United Kingdom	Rotherham District General Hospital-NHS Trust	Rotherham
United Kingdom	Salford Royal Hospitals NHS Trust	Salford	England
United Kingdom	Northern General Hospital	Sheffield	England
United Kingdom	Sheffield Teaching Hospitals	Sheffield	England
United Kingdom	Solihull Hospital	Solihull	England

Sponsors (1)

Lead Sponsor	Collaborator
Queen's Medical Centre

Country where clinical trial is conducted

United Kingdom,