Condition category
Cancer
Date applied
01/07/2001
Date assigned
01/07/2001
Last edited
24/11/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Richard Logan

ORCID ID

Contact details

School of Community Health Sciences
Medical School
University of Nottingham
Nottingham
NG7 2UH
United Kingdom
+44 (0)115 823 0452
Richard.Logan@nottingham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ukCAP

Study information

Scientific title

Acronym

Study hypothesis

To determine whether aspirin (300 mg/day) and/or folic acid (0.5 mg/day) could be used to prevent further colorectal adenomas in the high risk group of patients with previous colorectal adenomas removed by colonoscopy.

Ethics approval

1. LREC approval (Nottingham): gained on 19/11/98 (ref: EC98/203)
2. MREC approval (Trent): gained on 02/12/03 (ref: 98/4/055)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Condition

Recurrent colorectal adenomas

Intervention

Arm A: aspirin and folate
Arm B: aspirin and placebo folate
Arm C: placebo aspirin and folate
Arm D: placebo aspirin and placebo folate

Aspirin 300 mg E.C/day; folate 500 ug/day

Intervention type

Drug

Phase

Not Applicable

Drug names

Aspirin, folate

Primary outcome measures

Percentage of patients who developed one or more recurrent colorectal adenomas or cancers

Secondary outcome measures

1. Number of recurrent adenomas detected during follow-up
2. Percentage of patients who developed advanced colorectal neoplasia during follow-up

Overall trial start date

01/12/1997

Overall trial end date

01/07/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Eligible patients who have had:
1. Removal of adenomas greater than 0.5 cm after fixation or adenomas greater than 0.7 cm at the time of removal, within the last six months
2. A previous history of removal of such adenomas and have had adenoma of any size removed in the six months prior to recruitment These adenomas will be histologically confirmed and removed by either colonoscopy, flexi-sigmoidoscopy or via Transanal Endoscopic Microsurgery (TEMS) procedure

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1,000

Participant exclusion criteria

1. Over 75 years at time of recruitment
2. Serious medical conditions likely to preclude successful completion of the trial
3. Existing use of prescribed Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) including aspirin
4. Known aspirin intolerance or sensitivity
5. Active bleeding disorders or upper Gastrointestinal (GI) ulceration, including use of anticoagulants
6. Previous resection of the large bowel

Recruitment start date

01/12/1997

Recruitment end date

01/07/2005

Locations

Countries of recruitment

Denmark, United Kingdom

Trial participating centre

School of Community Health Sciences
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Organisation

Cancer Research UK (CRUK) (UK)

Sponsor details

PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
+44 (0)207 317 5186
kate.law@cancer.org.uk

Sponsor type

Charity

Website

http://www.cancer.org.uk

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18022173

Publication citations

  1. Results

    Logan RF, Grainge MJ, Shepherd VC, Armitage NC, Muir KR, , Aspirin and folic acid for the prevention of recurrent colorectal adenomas., Gastroenterology, 2008, 134, 1, 29-38, doi: 10.1053/j.gastro.2007.10.014.

Additional files

Editorial Notes