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
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
-
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.
-
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.