Long-term effect of resistant starch on cancer risk in carriers of hereditary colorectal cancer: an analysis from the CAPP2 randomised controlled trial

CAPP 2 Investigators; John C. Mathers; Mohammad Movahedi; Finlay Macrae; Jukka-Pekka Mecklin; Gabriela Moeslein; Sylviane Olschwang; Diana Eccles; Gareth Evans; Eamonn R. Maher; Lucio Bertario; Marie-Luise Bisgaard; Malcolm Dunlop; Judy W. C. Ho; Shirley Hodgson; Annika Lindblom; Jan Lubinski; Patrick J. Morrison; Victoria Murday; Raj Ramesar; Lucy Side; Rodney J. Scott; Huw J. W. Thomas; Hans Vasen; Anne-Marie Gerdes; Gail Barker; Gillian Crawford; Faye Elliott; Kirsi Pylvanainen; Juul Wijnen; Riccardo Fodde; Henry Lynch; D. Timothy Bishop; John Burn

doi:10.1016/S1470-2045(12)70475-8

Long-term effect of resistant starch on cancer risk in carriers of hereditary colorectal cancer: an analysis from the CAPP2 randomised controlled trial

CAPP 2 Investigators, John C. Mathers^*, Mohammad Movahedi, Finlay Macrae, Jukka-Pekka Mecklin, Gabriela Moeslein, Sylviane Olschwang, Diana Eccles, Gareth Evans, Eamonn R. Maher, Lucio Bertario, Marie-Luise Bisgaard, Malcolm Dunlop, Judy W. C. Ho, Shirley Hodgson, Annika Lindblom, Jan Lubinski, Patrick J. Morrison, Victoria Murday, Raj RamesarLucy Side, Rodney J. Scott, Huw J. W. Thomas, Hans Vasen, Anne-Marie Gerdes, Gail Barker, Gillian Crawford, Faye Elliott, Kirsi Pylvanainen, Juul Wijnen, Riccardo Fodde, Henry Lynch, D. Timothy Bishop, John Burn

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

Abstract / Description of output

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.

Original language	English
Pages (from-to)	1242-1249
Number of pages	8
Journal	The Lancet Oncology
Volume	13
Issue number	12
DOIs	https://doi.org/10.1016/S1470-2045(12)70475-8
Publication status	Published - Dec 2012

Keywords / Materials (for Non-textual outputs)

RECURRENCE
ASPIRIN
HIGH-FIBER DIET
LYNCH-SYNDROME
INTESTINAL TUMORIGENESIS
COLONIC FERMENTATION
ADENOMAS
PREVENTION
BUTYRATE
LOW-FAT

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10.1016/S1470-2045(12)70475-8

Long-term effect of resistant starch on cancer risk in carriers of hereditary colorectal cancer an analysis from the CAPP2 randomised controlled trialFinal published version, 263 KB

http://www.sciencedirect.com/science/article/pii/S1470204512704758

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CAPP 2 Investigators, Mathers, J. C., Movahedi, M., Macrae, F., Mecklin, J.-P., Moeslein, G., Olschwang, S., Eccles, D., Evans, G., Maher, E. R., Bertario, L., Bisgaard, M.-L., Dunlop, M., Ho, J. W. C., Hodgson, S., Lindblom, A., Lubinski, J., Morrison, P. J., Murday, V., ... Burn, J. (2012). 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, 13(12), 1242-1249. https://doi.org/10.1016/S1470-2045(12)70475-8

@article{688c078935f4408aadf8f0ec8b31998a,

title = "Long-term effect of resistant starch on cancer risk in carriers of hereditary colorectal cancer: an analysis from the CAPP2 randomised controlled trial",

abstract = "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.",

keywords = "RECURRENCE, ASPIRIN, HIGH-FIBER DIET, LYNCH-SYNDROME, INTESTINAL TUMORIGENESIS, COLONIC FERMENTATION, ADENOMAS, PREVENTION, BUTYRATE, LOW-FAT",

author = "{CAPP 2 Investigators} and Mathers, {John C.} and Mohammad Movahedi and Finlay Macrae and Jukka-Pekka Mecklin and Gabriela Moeslein and Sylviane Olschwang and Diana Eccles and Gareth Evans and Maher, {Eamonn R.} and Lucio Bertario and Marie-Luise Bisgaard and Malcolm Dunlop and Ho, {Judy W. C.} and Shirley Hodgson and Annika Lindblom and Jan Lubinski and Morrison, {Patrick J.} and Victoria Murday and Raj Ramesar and Lucy Side and Scott, {Rodney J.} and Thomas, {Huw J. W.} and Hans Vasen and Anne-Marie Gerdes and Gail Barker and Gillian Crawford and Faye Elliott and Kirsi Pylvanainen and Juul Wijnen and Riccardo Fodde and Henry Lynch and Bishop, {D. Timothy} and John Burn",

year = "2012",

month = dec,

doi = "10.1016/S1470-2045(12)70475-8",

language = "English",

volume = "13",

pages = "1242--1249",

journal = "The Lancet Oncology",

issn = "1470-2045",

publisher = "Lancet Publishing Group",

number = "12",

}

CAPP 2 Investigators, Mathers, JC, Movahedi, M, Macrae, F, Mecklin, J-P, Moeslein, G, Olschwang, S, Eccles, D, Evans, G, Maher, ER, Bertario, L, Bisgaard, M-L, Dunlop, M, Ho, JWC, Hodgson, S, Lindblom, A, Lubinski, J, Morrison, PJ, Murday, V, Ramesar, R, Side, L, Scott, RJ, Thomas, HJW, Vasen, H, Gerdes, A-M, Barker, G, Crawford, G, Elliott, F, Pylvanainen, K, Wijnen, J, Fodde, R, Lynch, H, Bishop, DT & Burn, J 2012, '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, vol. 13, no. 12, pp. 1242-1249. https://doi.org/10.1016/S1470-2045(12)70475-8

TY - JOUR

T1 - Long-term effect of resistant starch on cancer risk in carriers of hereditary colorectal cancer

T2 - an analysis from the CAPP2 randomised controlled trial

AU - CAPP 2 Investigators

AU - Mathers, John C.

AU - Movahedi, Mohammad

AU - Macrae, Finlay

AU - Mecklin, Jukka-Pekka

AU - Moeslein, Gabriela

AU - Olschwang, Sylviane

AU - Eccles, Diana

AU - Evans, Gareth

AU - Maher, Eamonn R.

AU - Bertario, Lucio

AU - Bisgaard, Marie-Luise

AU - Dunlop, Malcolm

AU - Ho, Judy W. C.

AU - Hodgson, Shirley

AU - Lindblom, Annika

AU - Lubinski, Jan

AU - Morrison, Patrick J.

AU - Murday, Victoria

AU - Ramesar, Raj

AU - Side, Lucy

AU - Scott, Rodney J.

AU - Thomas, Huw J. W.

AU - Vasen, Hans

AU - Gerdes, Anne-Marie

AU - Barker, Gail

AU - Crawford, Gillian

AU - Elliott, Faye

AU - Pylvanainen, Kirsi

AU - Wijnen, Juul

AU - Fodde, Riccardo

AU - Lynch, Henry

AU - Bishop, D. Timothy

AU - Burn, John

PY - 2012/12

Y1 - 2012/12

N2 - 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.

AB - 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.

KW - RECURRENCE

KW - ASPIRIN

KW - HIGH-FIBER DIET

KW - LYNCH-SYNDROME

KW - INTESTINAL TUMORIGENESIS

KW - COLONIC FERMENTATION

KW - ADENOMAS

KW - PREVENTION

KW - BUTYRATE

KW - LOW-FAT

U2 - 10.1016/S1470-2045(12)70475-8

DO - 10.1016/S1470-2045(12)70475-8

M3 - Article

C2 - 23140761

SN - 1470-2045

VL - 13

SP - 1242

EP - 1249

JO - The Lancet Oncology

JF - The Lancet Oncology

IS - 12

ER -

Long-term effect of resistant starch on cancer risk in carriers of hereditary colorectal cancer: an analysis from the CAPP2 randomised controlled trial

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Keywords / Materials (for Non-textual outputs)

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