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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Long-term effect of resistant starch on cancer risk in carriers of hereditary colorectal cancer: An analysis from the CAPP2 randomised controlled trial
The Lancet Oncology, Volume 13, No. 12, Year 2012
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Description
Background: Observational studies report that higher intake of dietary fibre (a heterogeneous mix including non-starch polysaccharides and resistant starches) is associated with reduced risk of colorectal cancer, but no randomised trials with prevention of colorectal cancer as a primary endpoint have been done. We assessed the effect of resistant starch on the incidence of colorectal cancer. Methods: In the CAPP2 study, individuals with Lynch syndrome were randomly assigned in a two-by-two factorial design to receive 600 mg aspirin or aspirin placebo or 30 g resistant starch or starch placebo, for up to 4 years. Randomisation was done with a block size of 16. Post-intervention, patients entered into double-blind follow-up; participants and investigators were masked to treatment allocation. The primary endpoint for this analysis was development of colorectal cancer in participants randomly assigned to resistant starch or resistant-starch placebo with both intention-to-treat and per-protocol analyses. This study is registered, ISRCTN 59521990. Findings: 463 patients were randomly assigned to receive resistant starch and 455 to receive resistant-starch placebo. At a median follow-up 52·7 months (IQR 28·9-78·4), 53 participants developed 61 primary colorectal cancers (27 of 463 participants randomly assigned to resistant starch, 26 of 455 participants assigned to resistant-starch placebo). Intention-to-treat analysis of time to first colorectal cancer showed a hazard ratio (HR) of 1·40 (95% CI 0·78-2·56; p=0·26) and Poisson regression accounting for multiple primary events gave an incidence rate ratio (IRR) of 1·15 (95% CI 0·66-2·00; p=0·61). For those completing 2 years of intervention, per-protocol analysis yielded a HR of 1·09 (0·55-2·19, p=0·80) and an IRR of 0·98 (0·51-1·88, p=0·95). No information on adverse events was gathered during post-intervention follow-up. Interpretation: Resistant starch had no detectable effect on cancer development in carriers of hereditary colorectal cancer. Dietary supplementation with resistant starch does not emulate the apparently protective effect of diets rich in dietary fibre against colorectal cancer. Funding: European Union, Cancer Research UK, Bayer Corporation, National Starch and Chemical Co, UK Medical Research Council, Newcastle Hospitals Trustees, Cancer Council of Victoria Australia, THRIPP South Africa, The Finnish Cancer Foundation, SIAK Switzerland, and Bayer Pharma. © 2012 Elsevier Ltd.
Authors & Co-Authors
Mathers, John C.
United Kingdom, Newcastle
University of Newcastle Upon Tyne, Faculty of Medical Sciences
Movahedi, Mohammad
United Kingdom, Leeds
University of Leeds, School of Medicine
Iran, Tehran
Shahid Beheshti University of Medical Sciences
MacRae, Finlay Alistair
Australia, Melbourne
Royal Melbourne Hospital
Mecklin, Jukka Pekka
Finland, Jyvaskyla
Jyvaskyla Central Hospital
Möeslein, Gabriela
Germany, Bochum
Helios St. Josefs-hospital Bochum-linden
Ołschwang, Sylviane
France, Marseille
Institut Paoli-calmettes
Eccles, Diana M.
United Kingdom, Southampton
University of Southampton, Faculty of Medicine
Evans, D. Gareth R.
United Kingdom, London
St Mary's Hospital
Mäher, Eamonn Richard
United Kingdom, Birmingham
University of Birmingham
Bertario, Lucio
Italy, Milan
Fondazione Irccs Istituto Nazionale Dei Tumori, Milan
Bisgaard, Marie Luise
Denmark, Copenhagen
Københavns Universitet
Dunlop, Malcolm G.
United Kingdom, Edinburgh
Western General Hospital
Ho, Judy Wai Chu
Hong Kong
Queen Mary Hospital Hong Kong
Hodgson, Shirley Victoria
United Kingdom, London
St George's Hospital
Lindblöm, Annika
Sweden, Stockholm
Karolinska Institutet
Lubiński, Jan
Poland, Szczecin
International Hereditary Cancer Centre
Morrison, Patrick J.
United Kingdom, Belfast
Queen's University Belfast
Murday, Victoria A.
United Kingdom, Glasgow
Institute of Medical Genetics
Ramesar, Rajkumar S.
South Africa, Cape Town
University of Cape Town
Side, Lucy E.
United Kingdom, Oxford
Churchill Hospital
Scott, Rodney J.
Australia, Newcastle
Hunter Area Pathology Service
Thomas, Huw J.W.
United Kingdom, Harrow
St Mark’s Hospital
Vasen, Hans F.A.
Netherlands, Leiden
Leids Universitair Medisch Centrum
Gerdes, Anne Marie Axø
United Kingdom, Newcastle
University of Newcastle Upon Tyne, Faculty of Medical Sciences
Denmark, Copenhagen
Section of Clinical Genetics
Barker, Gail
United Kingdom, Newcastle
University of Newcastle Upon Tyne, Faculty of Medical Sciences
Crawford, Gillian C.
United Kingdom, Southampton
University of Southampton, Faculty of Medicine
Elliott, Faye
United Kingdom, Leeds
University of Leeds, School of Medicine
Pylvänäinen, Kirsi
Finland, Jyvaskyla
Jyvaskyla Central Hospital
Wijnen, Juul Th
Netherlands, Leiden
Leids Universitair Medisch Centrum
Fodde, Riccardo
Netherlands, Rotterdam
Erasmus Mc
Lynch, Henry T.
United States, Omaha
Creighton University Medical Center
Bishop, D. Timothy
United Kingdom, Leeds
University of Leeds, School of Medicine
Burn, John
United Kingdom, Newcastle
University of Newcastle Upon Tyne, Faculty of Medical Sciences
Statistics
Citations: 33
Authors: 33
Affiliations: 27
Identifiers
Doi:
10.1016/S1470-2045(12)70475-8
ISSN:
14702045
e-ISSN:
14745488
Research Areas
Cancer
Disability
Environmental
Study Design
Randomised Control Trial
Cohort Study
Study Locations
South Africa