Condition category
Cancer
Date applied
18/08/2005
Date assigned
15/09/2005
Last edited
25/09/2012
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 John Burn

ORCID ID

Contact details

Institute of Human Genetics
Centre for Life
Central Parkway
Newcastle upon Tyne
NE1 3BZ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

Scientific title

Acronym

CAPP1

Study hypothesis

Daily use of aspirin and resistant starch will reduce the risk of polyp formation and of subsequent colon cancer.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Familial Adenomatous Polyposis (FAP)

Intervention

Factorial design of:
A. 600 mg Aspirin and 30 g Resistant Starch
B. Placebo Aspirin and 30 g Resistant Starch
C. 600 mg Aspirin and 30 g Placebo Starch
D. Placebo Aspirin and Placebo Starch

Intervention type

Drug

Phase

Not Specified

Drug names

Aspirin, resistant starch

Primary outcome measures

1. Age at colectomy
2. Reduction in size of polyps
3. Changes in crypt cell proliferation

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/1993

Overall trial end date

31/12/2003

Reason abandoned

Eligibility

Participant inclusion criteria

1. Known carriers of familial adenomatous polyposis (FAP), either by molecular genetic analysis or by phenotypic features
2. Over 10 years of age with an intact colon

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

400

Participant exclusion criteria

1. Already taking Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
2. Partial Resection
3. If over 21 years of age - to take treatment for 1 year only

Recruitment start date

01/01/1993

Recruitment end date

31/12/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of Human Genetics
Newcastle upon Tyne
NE1 3BZ
United Kingdom

Sponsor information

Organisation

Newcastle upon Tyne Hospitals NHS Trust (UK)

Sponsor details

R and D Department
Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Industry

Funder name

European Union Biomedical and Health Research - Biomed 1 Programme

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Bayer Corporation (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

1. 1995 protocol in http://www.ncbi.nlm.nih.gov/pubmed/7577057
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21543343

Publication citations

  1. Protocol

    Burn J, Chapman PD, Mathers J, Bertario L, Bishop DT, Bülow S, Cummings J, Phillips R, Vasen H, The protocol for a European double-blind trial of aspirin and resistant starch in familial adenomatous polyposis: the CAPP study. Concerted Action Polyposis Prevention., Eur. J. Cancer, 31A, 7-8, 1385-1386.

  2. Results

    Burn J, Bishop DT, Chapman PD, Elliott F, Bertario L, Dunlop MG, Eccles D, Ellis A, Evans DG, Fodde R, Maher ER, Möslein G, Vasen HF, Coaker J, Phillips RK, Bülow S, Mathers JC, , A randomized placebo-controlled prevention trial of aspirin and/or resistant starch in young people with familial adenomatous polyposis., Cancer Prev Res (Phila), 2011, 4, 5, 655-665, doi: 10.1158/1940-6207.CAPR-11-0106.

Additional files

Editorial Notes