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BMC Cancer
Published in: BMC Cancer 1/2014

Open Access 01-12-2014 | Study protocol

The COLON study: Colorectal cancer: Longitudinal, Observational study on Nutritional and lifestyle factors that may influence colorectal tumour recurrence, survival and quality of life

Authors: Renate M Winkels, Renate C Heine-Bröring, Moniek van Zutphen, Suzanne van Harten-Gerritsen, Dieuwertje EG Kok, Fränzel JB van Duijnhoven, Ellen Kampman

Published in: BMC Cancer | Issue 1/2014

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Abstract

Background

There is clear evidence that nutrition and lifestyle can modify colorectal cancer risk. However, it is not clear if those factors can affect colorectal cancer treatment, recurrence, survival and quality of life. This paper describes the background and design of the “COlorectal cancer: Longitudinal, Observational study on Nutritional and lifestyle factors that may influence colorectal tumour recurrence, survival and quality of life” – COLON – study. The main aim of this study is to assess associations of diet and other lifestyle factors, with colorectal cancer recurrence, survival and quality of life. We extensively investigate diet and lifestyle of colorectal cancer patients at diagnosis and during the following years; this design paper focusses on the initial exposures of interest: diet and dietary supplement use, body composition, nutrient status (e.g. vitamin D), and composition of the gut microbiota.

Methods/Design

The COLON study is a multi-centre prospective cohort study among at least 1,000 incident colorectal cancer patients recruited from 11 hospitals in the Netherlands. Patients with colorectal cancer are invited upon diagnosis. Upon recruitment, after 6 months, 2 years and 5 years, patients fill out food-frequency questionnaires; questionnaires about dietary supplement use, physical activity, weight, height, and quality of life; and donate blood samples. Diagnostic CT-scans are collected to assess cross-sectional areas of skeletal muscle, subcutaneous fat, visceral fat and intermuscular fat, and to assess muscle attenuation. Blood samples are biobanked to facilitate future analyse of biomarkers, nutrients, DNA etc. Analysis of serum 25-hydroxy vitamin D levels, and analysis of metabolomic profiles are scheduled. A subgroup of patients with colon cancer is asked to provide faecal samples before and at several time points after colon resection to study changes in gut microbiota during treatment. For all patients, information on vital status is retrieved by linkage with national registries. Information on clinical characteristics is gathered from linkage with the Netherlands Cancer Registry and with hospital databases. Hazards ratios will be calculated for dietary and lifestyle factors at diagnosis in relation to recurrence and survival. Repeated measures analyses will be performed to assess changes over time in dietary and other factors in relation to recurrence and survival.
Appendix
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Literature
1.
Ferlay J, Shin H-R, Bray F, Forman D, Mathers C, Parkin DM: Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer. 2010, 127 (12): 2893-2917. 10.1002/ijc.25516.CrossRefPubMed
2.
3.
World Cancer Research Fund/American Institute for Cancer Research: Food, Nutrition, Physical activity, and the prevention of Cancer: a global perspective. 2007, Washington DC: AICR
4.
Vrieling A, Kampman E: The role of body mass index, physical activity, and diet in colorectal cancer recurrence and survival: a review of the literature. Am J Clin Nutr. 2010, 92 (3): 471-490. 10.3945/ajcn.2009.29005.CrossRefPubMed
5.
Demark-Wahnefried W, Aziz NM, Rowland JH, Pinto BM: Riding the crest of the teachable moment: promoting long-term health after the diagnosis of cancer. J Clin Oncol. 2005, 23 (24): 5814-5830. 10.1200/JCO.2005.01.230.CrossRefPubMedPubMedCentral
6.
Demark-Wahnefried W, Jones LW: Promoting a healthy lifestyle among Cancer survivors. Hematol Oncol Clin North Am. 2008, 22 (2): 319-342. 10.1016/j.hoc.2008.01.012.CrossRefPubMedPubMedCentral
7.
Demark-Wahnefried W, Pinto BM, Gritz ER: Promoting health and physical function among cancer survivors: potential for prevention and questions that remain. J Clin Oncol. 2006, 24 (32): 5125-5131. 10.1200/JCO.2006.06.6175.CrossRefPubMed
8.
Meyerhardt JA, Niedzwiecki D, Hollis D, Saltz LB, Hu FB, Mayer RJ, Nelson H, Whittom R, Hantel A, Thomas J, Fuchs CS: Association of dietary patterns with cancer recurrence and survival in patients with stage III colon cancer. JAMA. 2007, 298 (7): 754-764. 10.1001/jama.298.7.754.CrossRefPubMed
9.
Velicer CM, Ulrich CM: Vitamin and mineral supplement use among US adults after cancer diagnosis: a systematic review. J Clin Oncol. 2008, 26 (4): 665-673. 10.1200/JCO.2007.13.5905.CrossRefPubMed
10.
Ng K, Meyerhardt JA, Chan JA, Niedzwiecki D, Hollis DR, Saltz LB, Mayer RJ, Benson AB, Schaefer PL, Whittom R, Hantel A, Goldberg RM, Fuchs CS: Multivitamin use is not associated with cancer recurrence or survival in patients with stage III colon cancer: findings from CALGB 89803. J Clin Oncol. 2010, 28 (28): 4354-4363. 10.1200/JCO.2010.28.0362.CrossRefPubMedPubMedCentral
11.
Kim YI: Role of folate in colon cancer development and progression. J Nutr. 2003, 133 (11 Suppl 1): 3731S-3739S.PubMed
12.
Boyle T, Fritschi L, Platell C, Heyworth J: Lifestyle factors associated with survival after colorectal cancer diagnosis. Br J Cancer. 2013, 109 (3): 814-822. 10.1038/bjc.2013.310.CrossRefPubMedPubMedCentral
13.
Campbell PT, Patel AV, Newton CC, Jacobs EJ, Gapstur SM: Associations of recreational physical activity and leisure time spent sitting with colorectal cancer survival. J Clin Oncol. 2013, 31 (7): 876-885. 10.1200/JCO.2012.45.9735.CrossRefPubMed
14.
Demark-Wahnefried W, Platz EA, Ligibel JA, Blair CK, Courneya KS, Meyerhardt JA, Ganz PA, Rock CL, Schmitz KH, Wadden T, Philip EJ, Wolfe B, Gapstur SM, Ballard-Barbash R, McTiernan A, Minasian L, Nebeling L, Goodwin PJ: The role of obesity in cancer survival and recurrence. Cancer Epidemiol Biomarkers Prev. 2012, 21 (8): 1244-1259. 10.1158/1055-9965.EPI-12-0485.CrossRefPubMedPubMedCentral
15.
Sinicrope FA, Foster NR, Yothers G, Benson A, Seitz JF, Labianca R, Goldberg RM, Degramont A, O'Connell MJ, Sargent DJ: Body mass index at diagnosis and survival among colon cancer patients enrolled in clinical trials of adjuvant chemotherapy. Cancer. 2013, 119 (8): 1528-1536. 10.1002/cncr.27938.CrossRefPubMedPubMedCentral
16.
Meyerhardt JA, Catalano PJ, Haller DG, Mayer RJ, Benson AB, Macdonald JS, Fuchs CS: Influence of body mass index on outcomes and treatment-related toxicity in patients with colon carcinoma. Cancer. 2003, 98 (3): 484-495. 10.1002/cncr.11544.CrossRefPubMed
17.
Meyerhardt JA, Niedzwiecki D, Hollis D, Saltz LB, Mayer RJ, Nelson H, Whittom R, Hantel A, Thomas J, Fuchs CS: Impact of body mass index and weight change after treatment on cancer recurrence and survival in patients with stage III colon cancer: findings from Cancer and Leukemia Group B 89803. J Clin Oncol. 2008, 26 (25): 4109-4115. 10.1200/JCO.2007.15.6687.CrossRefPubMedPubMedCentral
18.
Meyerhardt JA, Tepper JE, Niedzwiecki D, Hollis DR, McCollum AD, Brady D, O'Connell MJ, Mayer RJ, Cummings B, Willett C, Macdonald JS, Benson AB, Fuchs CS: Impact of body mass index on outcomes and treatment-related toxicity in patients with stage II and III rectal cancer: findings from Intergroup Trial 0114. J Clin Oncol. 2004, 22 (4): 648-657. 10.1200/JCO.2004.07.121.CrossRefPubMed
19.
Evans PD, McIntyre NJ, Fluck RJ, McIntyre CW, Taal MW: Anthropomorphic measurements that include central fat distribution are more closely related with key risk factors than BMI in CKD stage 3. PLoS One. 2012, 7 (4): e34699-10.1371/journal.pone.0034699.CrossRefPubMedPubMedCentral
20.
Martin L, Birdsell L, Macdonald N, Reiman T, Clandinin MT, McCargar LJ, Murphy R, Ghosh S, Sawyer MB, Baracos VE: Cancer Cachexia in the age of obesity: skeletal muscle depletion is a powerful prognostic factor, independent of body mass index. J Clin Oncol. 2013, 31 (12): 1539-1547. 10.1200/JCO.2012.45.2722.CrossRefPubMed
21.
Prado CM, Lieffers JR, McCargar LJ, Reiman T, Sawyer MB, Martin L, Baracos VE: Prevalence and clinical implications of sarcopenic obesity in patients with solid tumours of the respiratory and gastrointestinal tracts: a population-based study. Lancet Oncol. 2008, 9 (7): 629-635. 10.1016/S1470-2045(08)70153-0.CrossRefPubMed
22.
Ballian N, Lubner MG, Munoz A, Harms BA, Heise CP, Foley EF, Kennedy GD: Visceral obesity is associated with outcomes of total mesorectal excision for rectal adenocarcinoma. J Surg Oncol. 2012, 105 (4): 365-370. 10.1002/jso.22031.CrossRefPubMed
23.
Guiu B, Petit JM, Bonnetain F, Ladoire S, Guiu S, Cercueil JP, Krause D, Hillon P, Borg C, Chauffert B, Ghiringhelli F: Visceral fat area is an independent predictive biomarker of outcome after first-line bevacizumab-based treatment in metastatic colorectal cancer. Gut. 2010, 59 (3): 341-347. 10.1136/gut.2009.188946.CrossRefPubMed
24.
Moon HG, Ju YT, Jeong CY, Jung EJ, Lee YJ, Hong SC, Ha WS, Park ST, Choi SK: Visceral obesity may affect oncologic outcome in patients with colorectal cancer. Ann Surg Oncol. 2008, 15 (7): 1918-1922. 10.1245/s10434-008-9891-4.CrossRefPubMed
25.
Rickles AS, Iannuzzi JC, Mironov O, Deeb AP, Sharma A, Fleming FJ, Monson JRT: Visceral obesity and colorectal cancer: are we missing the boat with BMI?. J Gastrointest Surg. 2013, 17 (1): 133-143. 10.1007/s11605-012-2045-9.CrossRefPubMed
26.
Clark W, Siegel EM, Chen YA, Zhao X, Parsons CM, Hernandez JM, Weber J, Thareja S, Choi J, Shibata D: Quantitative measures of visceral adiposity and body mass index in predicting rectal cancer outcomes after neoadjuvant chemoradiation. J Am Coll Surg. 2013, 216 (6): 1070-1081. 10.1016/j.jamcollsurg.2013.01.007.CrossRefPubMedPubMedCentral
27.
Maalmi H, Ordóñez-Mena JM, Schöttker B, Brenner H: Serum 25-hydroxyvitamin D levels and survival in colorectal and breast cancer patients: Systematic review and meta-analysis of prospective cohort studies. Eur J Cancer. 2014, e-pub ahead of print(0)
28.
Andre T, Boni C, Mounedji-Boudiaf L, Navarro M, Tabernero J, Hickish T, Topham C, Zaninelli M, Clingan P, Bridgewater J, Tabah-Fisch I, de Gramont A: Oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment for colon cancer. N Engl J Med. 2004, 350 (23): 2343-2351. 10.1056/NEJMoa032709.CrossRefPubMed
29.
Yothers G, O'Connell MJ, Allegra CJ, Kuebler JP, Colangelo LH, Petrelli NJ, Wolmark N: Oxaliplatin as adjuvant therapy for colon cancer: updated results of NSABP C-07 trial, including survival and subset analyses. J Clin Oncol. 2011, 29 (28): 3768-3774. 10.1200/JCO.2011.36.4539.CrossRefPubMedPubMedCentral
30.
31.
van Vliet MJ, Harmsen HJ, de Bont ES, Tissing WJ: The role of intestinal microbiota in the development and severity of chemotherapy-induced mucositis. PLoS Pathog. 2010, 6 (5): e1000879-10.1371/journal.ppat.1000879.CrossRefPubMedPubMedCentral
32.
van Vliet MJ, Tissing WJ, Dun CA, Meessen NE, Kamps WA, de Bont ES, Harmsen HJ: Chemotherapy treatment in pediatric patients with acute myeloid leukemia receiving antimicrobial prophylaxis leads to a relative increase of colonization with potentially pathogenic bacteria in the gut. Clin Infect Dis. 2009, 49 (2): 262-270. 10.1086/599346.CrossRefPubMed
33.
Zwielehner J, Lassl C, Hippe B, Pointner A, Switzeny OJ, Remely M, Kitzweger E, Ruckser R, Haslberger AG: Changes in human fecal microbiota due to chemotherapy analyzed by TaqMan-PCR, 454 sequencing and PCR-DGGE fingerprinting. PLoS One. 2011, 6 (12): e28654-10.1371/journal.pone.0028654.CrossRefPubMedPubMedCentral
34.
Feunekes I, van Staveren W, Graveland F, De Vos J, Burema J: Reproducibility of a semiquantitative food frequency questionnaire to assess the intake of fats and cholesterol in The Netherlands. Int J Food Sci Nutr. 1995, 46: 117-123. 10.3109/09637489509012539.CrossRefPubMed
35.
Verkleij-Hagoort AC, de Vries JH, Stegers MP, Lindemans J, Ursem NT, Steegers-Theunissen RP: Validation of the assessment of folate and vitamin B12 intake in women of reproductive age: the method of triads. Eur J Clin Nutr. 2007, 61 (5): 610-615.PubMed
36.
Netherlands Nutrition Center: Dutch Nutrition Center. NEVO Nederlandse Voedingsmiddelentabel (In English: Dutch Food Composition Table). 2006, The Hague
37.
Mourtzakis M, Prado CMM, Lieffers JR, Reiman T, McCargar LJ, Baracos VE: A practical and precise approach to quantification of body composition in cancer patients using computed tomography images acquired during routine care. Appl Physiol Nutr Metab. 2008, 33 (5): 997-1006. 10.1139/H08-075.CrossRefPubMed
38.
Shen W, Punyanitya M, Wang Z, Gallagher D, St-Onge MP, Albu J, Heymsfield SB, Heshka S: Visceral adipose tissue: relations between single-slice areas and total volume. Am J Clin Nutr. 2004, 80 (2): 271-278.PubMedPubMedCentral
39.
Shen W, Punyanitya M, Wang Z, Gallagher D, St-Onge MP, Albu J, Heymsfield SB, Heshka S: Total body skeletal muscle and adipose tissue volumes: estimation from a single abdominal cross-sectional image. J Appl Physiol. 2004, 97 (6): 2333-2338. 10.1152/japplphysiol.00744.2004.CrossRefPubMed
40.
Wendel-Vos GC, Schuit AJ, Saris WH, Kromhout D: Reproducibility and relative validity of the short questionnaire to assess health-enhancing physical activity. J Clin Epidemiol. 2003, 56 (12): 1163-1169. 10.1016/S0895-4356(03)00220-8.CrossRefPubMed
41.
Ainsworth BE, Haskell WL, Herrmann SD, Meckes N, Bassett DR, Tudor-Locke C, Greer JL, Vezina J, Whitt-Glover MC, Leon AS: 2011 compendium of physical activities: a second update of codes and MET values. Med Sci Sports Exerc. 2011, 43 (8): 1575-1581. 10.1249/MSS.0b013e31821ece12.CrossRefPubMed
42.
De Hollander EL, Zwart L, De Vries SI, Wendel-Vos W: The SQUASH was a more valid tool than the OBiN for categorizing adults according to the Dutch physical activity and the combined guideline. J Clin Epidemiol. 2012, 65 (1): 73-81. 10.1016/j.jclinepi.2011.05.005.CrossRefPubMed
43.
Wagenmakers R, Akker-Scheek IVD, Groothoff JW, Zijlstra W, Bulstra SK, Kootstra JWJ, Wendel-Vos GCW, Van Raaij JJAM, Stevens M: Reliability and validity of the short questionnaire to assess health-enhancing physical activity (SQUASH) in patients after total hip arthroplasty. BMC Musculoskelet Disord. 2008, 9: 141-10.1186/1471-2474-9-141.CrossRefPubMedPubMedCentral
44.
van den Ouweland JM, Beijers AM, Demacker PN, van Daal H: Measurement of 25-OH-vitamin D in human serum using liquid chromatography tandem-mass spectrometry with comparison to radioimmunoassay and automated immunoassay. J Chromatogr B Analyt Technol Biomed Life Sci. 2010, 878 (15–16): 1163-1168.CrossRefPubMed
45.
Rajilic-Stojanovic M, Heilig HGHJ, Molenaar D, Kajander K, Surakka A, Smidt H, de Vos WM: Development and application of the human intestinal tract chip, a phylogenetic microarray: analysis of universally conserved phylotypes in the abundant microbiota of young and elderly adults. Environ Microbiol. 2009, 11 (7): 1736-1751. 10.1111/j.1462-2920.2009.01900.x.CrossRefPubMedPubMedCentral
46.
Aaronson NK, Ahinedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, De Haes JCJM, Kaasa S, Klee M, Osoba D, Razavi D, Rofe PB, Schraub S, Sneeuw K, Sullivan M, Takeda F: The european organization for research and treatment of cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993, 85 (5): 365-376. 10.1093/jnci/85.5.365.CrossRefPubMed
47.
Fayers P, Aaronson NK, Bjordal K, Groenvold M, Curran D, Bottomley A, on behalf of the European Quality of Life Group: The EORTC QLQ-C30 scoring manual. 3
48.
Postma TJ, Aaronson NK, Heimans JJ, Muller MJ, Hildebrand JG, Delattre JY, Hoang-Xuan K, Lantéri-Minet M, Grant R, Huddart R, Moynihan C, Maher J, Lucey R: EORTC Quality of Life Group: the development of an EORTC quality of life questionnaire to assess chemotherapy-induced peripheral neuropathy: the QLQ-CIPN20. Eur J Cancer. 2005, 41 (8): 1135-1139. 10.1016/j.ejca.2005.02.012.CrossRefPubMed
49.
Smith EML, Barton DL, Qin R, Steen PD, Aaronson NK, Loprinzi CL: Assessing patient-reported peripheral neuropathy: the reliability and validity of the European Organization for Research and Treatment of Cancer QLQ-CIPN20 Questionnaire. Qual Life Res. 2013, 22 (10): 2787-2799. 10.1007/s11136-013-0379-8.CrossRef
50.
Endler NS, Parker JDA: Assessment of multidimensional coping: task, emotion, and avoidance strategies. Psychol Assess. 1994, 6 (1): 50-60.CrossRef
51.
Ocke MC, Buurma-Rethans EJM, De Boer EJ, Wilson-vanden Hooven C, Etemad-Ghameslou Z, Drijvers JJMM, Van Rossum CTM: Diet of community-dwelling older adults: Dutch National Food Consumption Survey Older adults 2010–2012. Edited by: RIVM. 2013, 127-vol. RIVM report 050413001
52.
O'Connell JB, Maggard MA, Ko CY: Colon cancer survival rates with the new American Joint Committee on Cancer sixth edition staging. J Natl Cancer Inst. 2004, 96 (19): 1420-1425. 10.1093/jnci/djh275.CrossRefPubMed
53.
Van Roekel EH, Bours MJL, de Brouwer CPM, Ten Napel H, Sanduleanu S, Beets GL, Kant I, Weijenberg MP: The applicability of the International classification of functioning, disability and health to study lifestyle and quality of life of colorectal cancer survivors. Cancer Epidemiol Biomarkers Prev. 2014, e-pub ahead of print
54.
Schrotz-King P, Dölp K, Paskow M, Buck K, Abbenhardt C, Staffa J, Tosic S, Widmer V, Scherer D, Habermann N, Vickers K, Wilbur RE, Hoffmeister M, Chang-Claude J, Brenner H, Ulrich CM: Abstract 81: dietary supplement use among German colorectal cancer patients: the ColoCare Study. Cancer Epidemiol Biomarkers Prev. 2012, 21 (11 Supplement): 81-CrossRef
Metadata
Title
The COLON study: Colorectal cancer: Longitudinal, Observational study on Nutritional and lifestyle factors that may influence colorectal tumour recurrence, survival and quality of life
Authors
Renate M Winkels
Renate C Heine-Bröring
Moniek van Zutphen
Suzanne van Harten-Gerritsen
Dieuwertje EG Kok
Fränzel JB van Duijnhoven
Ellen Kampman
Publication date
01-12-2014
Publisher
BioMed Central
Published in
BMC Cancer / Issue 1/2014
Electronic ISSN: 1471-2407
DOI
https://doi.org/10.1186/1471-2407-14-374

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