Condition category
Cancer
Date applied
06/05/2011
Date assigned
06/05/2011
Last edited
01/05/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof Mark Hull

ORCID ID

Contact details

Leeds Institute of Molecular Medicine
Beckett Street
Leeds
LS9 7TF
United Kingdom
-
m.a.hull@leeds.ac.uk

Additional identifiers

EudraCT number

2010-020943-10

ClinicalTrials.gov number

Protocol/serial number

9734

Study information

Scientific title

A randomised controlled trial of eicosapentaenoic acid (EPA) and/or aspirin for colorectal adenoma (or polyp) prevention during colonoscopic surveillance in the NHS Bowel Cancer Screening Programme: The seAFOod (Systematic Evaluation of Aspirin and Fish Oil) polyp prevention trial

Acronym

The seAFOod Polyp Prevention Trial

Study hypothesis

The seAFOod Polyp Prevention Trial is a randomised, double-blind, placebo-controlled 2 x 2 factorial study. The trial has been designed to integrate fully into the screening and surveillance phases of the NHS Bowel Cancer Screening Programme (BCSP) so that participation will not alter routine clinical practice.

On 01/05/2015 the overall end date was changed from 29/05/2013 to 31/07/2017.

Ethics approval

East Midlands - Derby 1 First MREC approved on 24/11/2010, 10/H0405/90

Study design

Randomised; Interventional; Design type: Prevention

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Patient information can be found at: http://www.seafood-trial.co.uk (under useful documents section)

Condition

Topic: National Cancer Research Network, Oral and Gastrointestinal; Subtopic: Colorectal Cancer, Oral and Gastrointestinal (all Subtopics); Disease: Colon, Gastrointestinal

Intervention

The trial has a 2x2 factorial design with four treatment arms as follows:

1. EPA as the free fatty acid 1 g twice daily plus aspirin EC 300 mg once daily
2. EPA as the free fatty acid 1 g twice daily plus aspirin placebo once daily
3. EPA placebo twice daily plus aspirin EC 300 mg once daily
4. EPA placebo twice daily plus aspirin placebo once daily

Intervention type

Drug

Phase

Not Applicable

Drug names

Eicosapentaenoic acid (EPA), aspirin

Primary outcome measures

The number of patients with one or more adenomas; Timepoint(s): BCSP surveillance colonoscopy at 12 months

Secondary outcome measures

1. Adverse events, including clinically significant bleeding episodes; Timepoint(s): BCSP surveillance colonoscopy at 12 months
2. The number of 'advanced' adenomas per patient; Timepoint(s): BCSP surveillance colonoscopy at 12 months
3. The number of 'high risk' patients re-classified as 'intermediate risk'; Timepoint(s): BCSP surveillance colonoscopy at 12 months
4. The number of patients with one or more 'advanced' adenomas; Timepoint(s): BCSP surveillance colonoscopy at 12 months
5. The region of the colorectum that adenomas are detected; Timepoint(s): BCSP surveillance colonoscopy at 12 months
6. The total number of adenomas per patient; Timepoint(s): BCSP surveillance colonoscopy at 12 months

Overall trial start date

30/05/2011

Overall trial end date

31/07/2017

Reason abandoned

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 04/07/2013:
Recruitment will be restricted to 55-73 year-old NHS Bowel Cancer Screening Programme (BCSP) patients who have been identified as 'high risk' (5 or more small adenomas or more than 3 adenomas with at least one being >10 mm in diameter) after their first screening colonoscopy by either Faecal Occult Blood test (FOBt) or Flexible Sigmoidoscopy (FS); Target Gender: Male & Female; Upper Age Limit 73 years ; Lower Age Limit 55 years

Inclusion criteria from 29/05/2012 to 04/07/2013:
Recruitment will be restricted to 60-73 year-old NHS Bowel Cancer Screening Programme (BCSP) patients who have been identified as 'high risk' (5 or more small adenomas or more than 3 adenomas with at least one being >10 mm in diameter) after a single clearance screening colonoscopy.; Target Gender: Male & Female; Upper Age Limit 73 years ; Lower Age Limit 60 years

Original inclusion criteria:
Recruitment will be restricted to 60-75 year-old NHS Bowel Cancer Screening Programme (BCSP) patients who have been identified as 'high risk' (5 or more small adenomas or more than 3 adenomas with at least one being >10 mm in diameter) after a single clearance screening colonoscopy. Target Gender: Male & Female; Upper Age Limit 75 years ; Lower Age Limit 60 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 904; UK Sample Size: 904

Participant exclusion criteria

Current exclusion criteria as of 01/10/2012:
1. Requirement for more than one repeat colonoscopy or flexible sigmoidoscopy within the BCSP 3 month screening window
2. Malignant change in an adenoma requiring Colorectal Cancer Multi-disciplinary Team management
3. Regular (>3 doses per week) prescribed or over-the-counter (OTC) aspirin or regular (>3 doses per week) prescribed or OTC non-aspirin non-steroidal anti-inflammatory drug (NSAID) use
4. Aspirin intolerance or hypersensitivity, including aspirin-sensitive asthma
5. Active peptic ulcer disease within 3 months or previous peptic ulcer (not on proton pump inhibitor prophylaxis)
6. Fish or seafood allergy
7. Current or planned regular (>3 doses per week) use of fish oil supplements
8. Known clinical diagnosis or gene carrier of a hereditary colorectal cancer (CRC) predisposition (familial adenomatous polyposis (FAP), hereditary nonpolyposis colorectal cancer (HNPCC))
9. Previous or newly diagnosed inflammatory bowel disease
10. Previous or planned colorectal resection
11. Known bleeding diathesis or concomitant warfarin therapy or severe liver impairment
12. Severe renal failure (creatinine clearance < 10 ml/min)
13. Current methotrexate use at a weekly dose of 15 mg or more
14. Inability to comply with study procedures and agents
15. Serious medical illness interfering with study participation
16. Failure to give written informed consent

Previous exclusion criteria as of 29/05/2012 and until 01/10/2012:
1. Need for repeat colonoscopy or flexible sigmoidoscopy to check for adenoma excision within a 3 month window

Previous exclusion criteria
1. Need for repeat colonoscopy or flexible sigmoidoscopy to check for adenoma excision within a 3 month window
2. Malignant change in an adenoma requiring Colorectal Cancer Multi-disciplinary Team management
3. Regular (>3 doses per week) prescribed aspirin or regular (>3 doses per week) prescribed nonaspirin nonsteroidal antiinflammatory drug (NSAID) use
4. Aspirin intolerance or hypersensitivity, including aspirin-sensitive asthma
5. Active peptic ulcer disease within 3 months or previous peptic ulcer (not on proton pump inhibitor prophylaxis)
6. Fish or seafood allergy
7. Current or planned regular (>3 doses per week) use of fish oil supplements
8. Known clinical diagnosis or gene carrier of a hereditary colorectal cancer (CRC) predisposition (familial adenomatous polyposis (FAP), hereditary nonpolyposis colorectal cancer (HNPCC))
9. Previous or newly diagnosed inflammatory bowel disease
10. Previous or planned colorectal resection
11. Known bleeding diathesis or concomitant warfarin therapy or severe liver impairment
12. Severe renal failure (creatinine clearance < 10 ml/min)
13. Current methotrexate use at a weekly dose of 15 mg or more
14. Inability to comply with study procedures and agents
15. Serious medical illness interfering with study participation
16. Failure to give written informed consent

Recruitment start date

11/11/2011

Recruitment end date

30/06/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Participating centres across England, go to http://www.nottingham.ac.uk/mczseafood/centres.html for a list of sites
United Kingdom

Sponsor information

Organisation

University of Leeds (UK)

Sponsor details

School of Medicine
The Worsley Medical & Dental Building
Clarendon Way
Leeds
LS2 9NL
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

The Efficacy and Mechanism Evaluation Programme (MRC/NIHR) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23895505

Publication citations

Additional files

Editorial Notes