title: The muscle mass, omega-3, diet, exercise and lifestyle (MODEL) study - a randomised controlled trial for women who have completed breast cancer treatment.
abstract: BACKGROUND
  Loss of lean body mass (LBM) is a common occurrence after treatment for breast cancer and is related to deleterious metabolic health outcomes [Clin Oncol, 22(4):281-288, 2010; Appl Physiol Nutr Metab, 34(5):950-956, 2009]. The aim of this research is to determine the effectiveness of long chain omega-3 fatty acids (LCn-3s) and exercise training alone, or in combination, in addressing LBM loss in breast cancer survivors.
  
  
  METHODS
  A total of 153 women who have completed treatment for breast cancer in the last 12 months, with a Body Mass Index (BMI) of 20 to 35 kg/m2, will be randomly assigned to one of 3 groups: 3g/d LCn-3s (N-3), a 12-week nutrition and exercise education program plus olive oil (P-LC) or the education program plus LCn-3s (EX+N-3). Participants randomised to the education groups will be blinded to treatment, and will receive either olive oil placebo (OO+N-3) or LCn-3 provision, while the N-3 group will be open label. The education program includes nine 60-75 min sessions over 12 weeks that will involve breast cancer specific healthy eating advice, plus a supervised exercise session run as a resistance exercise circuit. They will also be advised to conduct the resistance training and aerobic training 5 to 7 days per week collectively. Outcome measures will be taken at baseline, 12-weeks and 24-weeks. The primary outcome is % change in LBM as measured by the air displacement plethysmograhy. Secondary outcomes include quality of life (FACT-B + 4) and inflammation (C-Reactive protein: CRP). Additional measures taken will be erythrocyte fatty acid analysis, fatigue, physical activity, menopausal symptoms, dietary intake, joint pain and function indices.
  
  
  CONCLUSIONS
  This research will provide the first insight into the efficacy of LCn-3s alone or in combination with exercise in breast cancer survivors with regards to LBM and quality of life. In addition, this study is designed to improve evidence-based dietetic practice, and how specific dietary prescription may link with appropriate exercise interventions.
  
  
  BACKGROUND
  ACTRN12610001005044; and World Health Organisation Universal trial number: U1111-1116-8520.
authors.affiliation: Centre for Dietetics Research, University of Queensland, Brisbane, Australia. c.mcdonald4@uq.edu.au.
authors.forename: Cameron
authors.initials: C
authors.lastname: McDonald
authors.forename: Judy
authors.initials: J
authors.lastname: Bauer
authors.forename: Sandra
authors.initials: S
authors.lastname: Capra
authors.forename: Joseph
authors.initials: J
authors.lastname: Coll
mesh_terms: D000328:Adult; D000368:Aged; D015992:Body Mass Index; D001943:Breast Neoplasms / Q000178:diet therapy* / Q000188:drug therapy / Q000473:pathology; D004032:Diet; D015444:Exercise; D015525:Fatty Acids, Omega-3 / Q000097:blood*; D005260:Female; D006801:Humans; D008019:Life Style; D008875:Middle Aged; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D015525:Fatty Acids, Omega-3
references.citation: Am J Clin Nutr. 2011 Feb;93(2):402-12
references.pmid: 21159787
references.citation: Int J Obes (Lond). 2006 Oct;30(10):1557-64
references.pmid: 16534529
references.citation: Physiol Res. 2008;57 Suppl 1:S57-S65
references.pmid: 18271691
references.citation: Cancer Prev Res (Phila). 2011 Apr;4(4):522-9
references.pmid: 21464032
references.citation: Breast Cancer Res Treat. 2007 Aug;104(2):145-52
references.pmid: 17058023
references.citation: J Hypertens. 2001 Oct;19(10):1745-54
references.pmid: 11593093
references.citation: Am J Clin Nutr. 2011 Feb;93(2):455-62
references.pmid: 21159785
references.citation: Cancer Epidemiol Biomarkers Prev. 2009 May;18(5):1403-9
references.pmid: 19366908
references.citation: Support Care Cancer. 2007 Feb;15(2):203-11
references.pmid: 17001492
references.citation: J Clin Oncol. 2009 Mar 10;27(8):1197-201
references.pmid: 19164208
references.citation: Appl Physiol Nutr Metab. 2009 Oct;34(5):950-6
references.pmid: 19935858
references.citation: Obesity (Silver Spring). 2009 Aug;17(8):1534-41
references.pmid: 19629060
references.citation: J Am Geriatr Soc. 2003 Nov;51(11):1602-9
references.pmid: 14687390
references.citation: J Am Diet Assoc. 1999 Oct;99(10):1222-7
references.pmid: 10524385
references.citation: Med Sci Sports Exerc. 2010 Jul;42(7):1409-26
references.pmid: 20559064
references.citation: Open Obes J. 2011;3:87-97
references.pmid: 22238561
references.citation: N Engl J Med. 2009 Aug 13;361(7):664-73
references.pmid: 19675330
references.citation: Maturitas. 1998 May 20;29(1):25-31
references.pmid: 9643514
references.citation: J Clin Oncol. 2001 May 1;19(9):2381-9
references.pmid: 11331316
references.citation: Clin Exerc Physiol. 2002 Feb;4(1):44-49
references.pmid: 16946801
references.citation: Nutr Metab (Lond). 2011 Oct 05;8:68
references.pmid: 21975196
references.citation: Int J Obes (Lond). 2007 Oct;31(10):1560-6
references.pmid: 17502874
references.citation: Eur J Intern Med. 2008 Dec;19(8):592-7
references.pmid: 19046724
references.citation: J Hum Nutr Diet. 2008 Dec;21(6):591-600
references.pmid: 18759956
references.citation: Nutr Metab (Lond). 2006 Aug 22;3:32
references.pmid: 16925811
references.citation: Breast Cancer Res Treat. 2008 Sep;111(2):365-72
references.pmid: 17922185
references.citation: Nutr Cancer. 2010;62(8):1142-52
references.pmid: 21058203
references.citation: J Int Soc Sports Nutr. 2010 Oct 08;7:31
references.pmid: 20932294
references.citation: Support Care Cancer. 2013 Feb;21(2):521-30
references.pmid: 22864470
references.citation: Int J Sports Med. 2006 Jul;27(7):573-80
references.pmid: 16802254
references.citation: Cancer Epidemiol. 2012 Jun;36(3):237-48
references.pmid: 22459198
references.citation: Int J Obes (Lond). 2011 Aug;35(8):1124-30
references.pmid: 21102553
references.citation: Am J Clin Nutr. 2012 Feb;95(2):428-36
references.pmid: 22218156
references.citation: Cancer Causes Control. 2008 Dec;19(10):1319-28
references.pmid: 18752034
references.citation: Cancer. 2003 Apr 1;97(7):1746-57
references.pmid: 12655532
references.citation: Can J Physiol Pharmacol. 2013 Jun;91(6):459-68
references.pmid: 23746140
references.citation: Cancer Epidemiol Biomarkers Prev. 2005 Jul;14(7):1672-80
references.pmid: 16030100
references.citation: Am J Cardiol. 2007 Mar 19;99(6A):44C-46C
references.pmid: 17368278
references.citation: Clin Breast Cancer. 2008 Feb;8(1):70-9
references.pmid: 18501061
references.citation: Br J Cancer. 2006 Jul 17;95(2):153-8
references.pmid: 16835585
references.citation: Curr Opin Clin Nutr Metab Care. 2012 May;15(3):246-51
references.pmid: 22366922
references.citation: Breast Cancer Res Treat. 2011 Jan;125(2):441-6
references.pmid: 21046232
references.citation: Clin J Oncol Nurs. 2007 Feb;11(1):41-52
references.pmid: 17441396
references.citation: Osteoporos Int. 2012 May;23(5):1601-12
references.pmid: 21892676
references.citation: J Rheumatol. 2003 Jan;30(1):167-78
references.pmid: 12508408
references.citation: J Natl Cancer Inst. 2011 Feb 2;103(3):178-231
references.pmid: 21217081
references.citation: Br J Nutr. 2012 Oct 28;108(8):1466-74
references.pmid: 22214842
references.citation: Breast Cancer Res Treat. 2011 Jun;127(2):447-56
references.pmid: 21424279
references.citation: Int J Obes (Lond). 2006 Oct;30(10):1535-44
references.pmid: 16552404
references.citation: Nutr Clin Pract. 2012 Aug;27(4):553-60
references.pmid: 22661243
references.citation: Palliat Med. 2012 Jun;26(4):294-304
references.pmid: 21865295
references.citation: Med Sci Sports Exerc. 2002 Mar;34(3):497-502
references.pmid: 11880815
references.citation: J Clin Oncol. 2005 Mar 1;23(7):1370-8
references.pmid: 15684320
references.citation: Clin Nurs Res. 2011 Feb;20(1):29-46
references.pmid: 20736382
references.citation: J Aging Phys Act. 2013 Jan;21(1):20-32
references.pmid: 22715064
references.citation: PLoS One. 2010 Aug 09;5(8):e12033
references.pmid: 20711498
references.citation: Obes Res. 2004 Feb;12(2):306-12
references.pmid: 14981223
references.citation: JPEN J Parenter Enteral Nutr. 1999 Sep-Oct;23(5):293-9
references.pmid: 10485442
references.citation: Cancer. 2012 Apr 15;118(8 Suppl):2277-87
references.pmid: 22488702
references.citation: Obes Rev. 2009 Nov;10(6):648-59
references.pmid: 19460115
references.citation: Breast Cancer Res Treat. 2001 Aug;68(3):273-82
references.pmid: 11727963
references.citation: J Clin Oncol. 1993 Mar;11(3):570-9
references.pmid: 8445433
references.citation: Breast Cancer Res Treat. 2012 Oct;135(3):663-80
references.pmid: 22903689
references.citation: J Clin Oncol. 2007 Oct 1;25(28):4396-404
references.pmid: 17785708
references.citation: Cancer Epidemiol Biomarkers Prev. 2009 Jan;18(1):306-13
references.pmid: 19124513
references.citation: CMAJ. 2006 Jul 4;175(1):34-41
references.pmid: 16818906
references.citation: Clin Oncol (R Coll Radiol). 2010 May;22(4):281-8
references.pmid: 20189371
references.citation: Cancer. 2008 Apr 15;112(8):1845-53
references.pmid: 18306372
references.citation: Biol Res Nurs. 2008 Jul;10(1):34-43
references.pmid: 18705153
references.citation: J Clin Oncol. 2012 Jul 1;30(19):2314-26
references.pmid: 22614972
references.citation: Clin Sci (Lond). 2011 Sep;121(6):267-78
references.pmid: 21501117
references.citation: Am J Clin Nutr. 2007 May;85(5):1267-74
references.pmid: 17490962
references.citation: Med Sci Sports Exerc. 1995 Dec;27(12):1686-91
references.pmid: 8614326
references.citation: J Clin Oncol. 1999 Jan;17(1):120-9
references.pmid: 10458225
references.citation: Med Oncol. 2011 Sep;28(3):753-65
references.pmid: 20411366