Aspirin and/or Folic Acid in Preventing Recurrent Colorectal Polyps

NCT00033319 | Unknown

• 3 other identifiers: CDR0000069273QMC-UKCAPEU-20045
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 32

Brief 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.

Conditions

Colorectal Cancer

Keywords

colon cancer; rectal cancer

Interventions

folic acid DIETARY_SUPPLEMENT

acetylsalicylic acid DRUG

Eligibility Criteria

• Age: Up to 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Queen's Medical Center: lead

Study Sites (32)

Antrim Hospital

Antrim, England, BR41 2RL, United Kingdom

Location

City Hospital - Birmingham

Birmingham, England, B18 7QH, United Kingdom

Location

Birmingham Heartlands and Solihull NHS Trust (Teaching)

Birmingham, England, B9 5SS, United Kingdom

Location

Southmead Hospital

Bristol, England, BS10 5NB, United Kingdom

Location

Frenchay Hospital

Bristol, England, BS16 1LE, United Kingdom

Location

Bristol Royal Infirmary

Bristol, England, BS2 8HW, United Kingdom

Location

Derby City General Hospital

Derby, England, DE22 3NE, United Kingdom

Location

Wordsley Hospital

Dudley, England, DY8 5QX, United Kingdom

Location

Glenfield Hospital

Leicester, England, LE3 9QP, United Kingdom

Location

Royal Liverpool and Broadgreen Hospitals

Liverpool, England, L7 8XP, United Kingdom

Location

Manchester Royal Infirmary

Manchester, England, M13 9WL, United Kingdom

Location

Wythenshawe Hospital

Manchester, England, M23 9LJ, United Kingdom

Location

Trafford General Hospital

Manchester, England, M31 3SL, United Kingdom

Location

Southport and Formby District General Hospital

Merseyside, England, PR8 6NJ, United Kingdom

Location

Merthyr Tydfil Hospital

Merthyr, England, United Kingdom

Location

Nottingham City Hospital NHS Trust

Nottingham, England, NG5 1PB, United Kingdom

Location

Queen's Medical Centre

Nottingham, England, NG7 2UH, United Kingdom

Location

Whiston Hospital

Prescot Merseyside, England, L35 5DR, United Kingdom

Location

Salford Royal Hospitals NHS Trust

Salford, England, M6 8HD, United Kingdom

Location

Sheffield Teaching Hospitals

Sheffield, England, S1O 2JF, United Kingdom

Location

Northern General Hospital

Sheffield, England, S5 7AU, United Kingdom

Location

Solihull Hospital

Solihull, England, B91 3AH, United Kingdom

Location

Royal Victoria Hospital

Belfast, Northern Ireland, BT12 6BA, United Kingdom

Location

Whiteabbey Hospital

Newtownabbey, Northern Ireland, United Kingdom

Location

Princess of Wales Hospital

Bridgend, Wales, CF31 1JP, United Kingdom

Location

University of Wales College of Medicine

Cardiff, Wales, CF14 4XN, United Kingdom

Location

Selly Oak Hospital

Birmingham, B29 6JD, United Kingdom

Location

East Glamorgan Hospital

Lhantrisant, CF72 8XR, United Kingdom

Location

North Manchester Healthcare NHS Trust

Manchester, M8 6RB, United Kingdom

Location

Royal Gwent Hospital

Newport Gwent, NP9 2UB, United Kingdom

Location

King's Mills Hospital

Nottinghamshire, NG17 4JL, United Kingdom

Location

Rotherham District General Hospital-NHS Trust

Rotherham, S60 2UD, United Kingdom

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Folic Acid; Aspirin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Richard Logan, MD

  Queen's Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: PREVENTION
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 9, 2002
• First Posted: July 1, 2003
• Study Start: May 1, 1997
• Last Updated: September 17, 2013

Record last verified: 2002-12

Locations

GB (32)