seAFOOD.
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 small adenomas; or ≥ 3 adenomas with at least one being ≥ 10 mm in diameter) after their 1st screening colonoscopy |
Interventions | Each for 12 months: Arm 1: EPA (ALFA capsules: 2 x 500 mg/d = 2 g/d) and aspirin placebo (1/d) Arm 2: EPA placebo (capric and caprylic acid triglycerides: 2/d) and aspirin EC (1/d = 300 mg/d) Arm 3: EPA (ALFA capsules: 2 x 500 mg/d = 2 g/d) and aspirin EC (1/d = 300 mg/d) Arm 4: EPA placebo (capric and caprylic acid triglycerides: 2/d) and aspirin placebo (1/d) |
Outcomes | Primary: number of participants with ≥ 1 adenomas at 12 months Secondary: adverse events, number of "advanced" adenomas per participant, number of "high risk" participants re‐classified as "intermediate risk", number participants with ≥ 1 advanced adenomas, adenoma region in the colorectum, total number of adenomas per participant, number of participants 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 trial 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 |