seAFOOD 2013.
Trial name or title | The seAFOod (systematic evaluation of Aspirin and Fish Oil) Polyp Prevention Trial |
Methods | RCT |
Participants | NHS Bowel Cancer Screening Programme patients (55‐73 years) identified as "high risk" (5 or more small adenomas; or 3 or more adenomas with at least one being 10 mm or more in diameter) after their 1st screening colonoscopy |
Interventions | Each for 12 months: Arm 1: EPA (ALFA capsules: 2 × 500 mg twice daily = 2 g/d) and aspirin placebo (1/d) Arm 2: EPA placebo (capric and capryllic acid triglycerides: 2/d) and aspirin (1/d = 300 mg/d) Arm 3: EPA (ALFA capsules: 2 × 500 mg twice daily = 2 g/d) and aspirin (1/d = 300 mg/d) Arm 4: EPA placebo (cparic and capryllic acid triglycerides: 2/d) and aspirin placebo (1/d) |
Outcomes | Primary: number of patients with one or more adenomas at 12 months Secondary: adverse events, number of "advanced" adenomas per patients, number of "high risk" patients re‐classified as "intermediate risk", number patients with one or more advanced adenomas, adenoma region in the colorectum, total number of adenomas per patient, number of patients with colorectal cancer, levels of bioactive lipid mediators e.g. omega‐3 |
Starting date | Trial Registration entry: 6 May 2011 Trial start date: 30 May 2011 Estimated study completion: 31 July 2017 |
Contact information | Mark Hull, Leeds Institute of Molecular Medicine, m.a.hull@leeds.ac.uk |
Notes | ISRCTN05926847 EudraCT 2010−020943−10 www.seafood‐trial.co.uk |