Exercise as a diagnostic and therapeutic tool for preventing cardiovascular morbidity in breast cancer patients- the BReast cancer EXercise InTervention (BREXIT) trial protocol.
Adult
Aged
Anthracyclines
/ adverse effects
Breast Neoplasms
/ drug therapy
Cancer Survivors
/ statistics & numerical data
Cardiotoxicity
/ diagnosis
Cardiovascular Diseases
/ chemically induced
Exercise Therapy
/ methods
Female
Follow-Up Studies
Humans
Middle Aged
Prognosis
Randomized Controlled Trials as Topic
Anthracycline
Cardiac reserve
Cardiotoxicity
Exercise training
Journal
BMC cancer
ISSN: 1471-2407
Titre abrégé: BMC Cancer
Pays: England
ID NLM: 100967800
Informations de publication
Date de publication:
14 Jul 2020
14 Jul 2020
Historique:
received:
11
05
2020
accepted:
01
07
2020
entrez:
16
7
2020
pubmed:
16
7
2020
medline:
11
3
2021
Statut:
epublish
Résumé
Anthracycline chemotherapy (AC) is an efficacious (neo) adjuvant treatment for early-stage breast cancer (BCa), but is associated with an increased risk of cardiac dysfunction and functional disability. Observations suggest that regular exercise may be a useful therapy for the prevention of cardiovascular morbidity but it is yet to be interrogated in a large randomised trial. The primary aims of this study are to: 1) determine if 12-months of ET commenced at the onset of AC can reduce the proportion of BCa patients with functional disability (peak VO One hundred women with early-stage BCa (40-75 years) scheduled for AC will be randomized to 12-months of structured exercise training (n = 50) or a usual care control group (n = 50). Participants will be assessed at baseline, 4-weeks following completion of AC (4-months) and at 12-months for all measures. Women diagnosed with early-stage BCa have increased cardiac mortality. More sensitive strategies for diagnosing and preventing AC-induced cardiovascular impairment are critical for reducing cardiovascular morbidity and improving long-term health outcomes in BCa survivors. Australia & New Zealand Clinical Trials Registry (ANZCTR), ID: 12617001408370 . Registered on 5th of October 2017.
Sections du résumé
BACKGROUND
BACKGROUND
Anthracycline chemotherapy (AC) is an efficacious (neo) adjuvant treatment for early-stage breast cancer (BCa), but is associated with an increased risk of cardiac dysfunction and functional disability. Observations suggest that regular exercise may be a useful therapy for the prevention of cardiovascular morbidity but it is yet to be interrogated in a large randomised trial. The primary aims of this study are to: 1) determine if 12-months of ET commenced at the onset of AC can reduce the proportion of BCa patients with functional disability (peak VO
METHODS
METHODS
One hundred women with early-stage BCa (40-75 years) scheduled for AC will be randomized to 12-months of structured exercise training (n = 50) or a usual care control group (n = 50). Participants will be assessed at baseline, 4-weeks following completion of AC (4-months) and at 12-months for all measures.
DISCUSSION
CONCLUSIONS
Women diagnosed with early-stage BCa have increased cardiac mortality. More sensitive strategies for diagnosing and preventing AC-induced cardiovascular impairment are critical for reducing cardiovascular morbidity and improving long-term health outcomes in BCa survivors.
TRIAL REGISTRATION
BACKGROUND
Australia & New Zealand Clinical Trials Registry (ANZCTR), ID: 12617001408370 . Registered on 5th of October 2017.
Identifiants
pubmed: 32664946
doi: 10.1186/s12885-020-07123-6
pii: 10.1186/s12885-020-07123-6
pmc: PMC7362469
doi:
Substances chimiques
Anthracyclines
0
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
655Subventions
Organisme : Wereld Kanker Onderzoek Fonds (NL)
ID : IIG_2019_1948
Organisme : National Heart Foundation of Australia
ID : 102021
Organisme : National Heart Foundation of Australia
ID : 102536
Références
J Clin Oncol. 2017 Mar 10;35(8):893-911
pubmed: 27918725
Med Sci Sports Exerc. 2001 Jul;33(7):1126-41
pubmed: 11445760
CA Cancer J Clin. 2016 Jan-Feb;66(1):7-30
pubmed: 26742998
Epidemiology. 2016 Jan;27(1):6-13
pubmed: 26414938
Med Sci Sports Exerc. 1998 Aug;30(8):1223-9
pubmed: 9710861
Breast Cancer Res Treat. 2018 Feb;167(3):719-729
pubmed: 29110150
Int J Cardiol. 2015 Jan 15;178:262-4
pubmed: 25464266
Circ Cardiovasc Imaging. 2013 Mar 1;6(2):329-38
pubmed: 23258478
J Pain Symptom Manage. 1997 Feb;13(2):63-74
pubmed: 9095563
J Am Geriatr Soc. 1975 Oct;23(10):433-41
pubmed: 1159263
Circulation. 2015 Jun 2;131(22):1981-8
pubmed: 25948538
J Am Coll Cardiol. 2007 Oct 9;50(15):1435-41
pubmed: 17919562
Ann Oncol. 2015 Sep;26 Suppl 5:v8-30
pubmed: 26314782
Acta Oncol. 2014 Jan;53(1):65-74
pubmed: 23957716
Med Sci Sports Exerc. 2010 Jul;42(7):1409-26
pubmed: 20559064
CA Cancer J Clin. 2016 Jul;66(4):271-89
pubmed: 27253694
Am J Cardiol. 2013 Dec 15;112(12):1980-4
pubmed: 24075281
Br Heart J. 1944 Jan;6(1):33-40
pubmed: 18609953
J Natl Cancer Inst. 2013 Dec 4;105(23):1821-32
pubmed: 24151326
Cochrane Database Syst Rev. 2016 Sep 21;9:CD005001
pubmed: 27650122
Front Nutr. 2014 Jun 16;1:5
pubmed: 25988109
J Am Coll Cardiol. 2014 Sep 2;64(9):938-45
pubmed: 25169180
J Am Coll Cardiol. 2013 Jan 8;61(1):77-84
pubmed: 23199515
J Am Coll Cardiol. 2016 Feb 23;67(7):780-9
pubmed: 26892413
PLoS One. 2013 Aug 14;8(8):e70993
pubmed: 23967145
Circulation. 2018 Apr 10;137(15):1549-1560
pubmed: 29311053
Am Heart J. 2017 Mar;185:35-42
pubmed: 28267473
Multivariate Behav Res. 1991 Jul 1;26(3):499-510
pubmed: 26776715
Circulation. 2016 Mar 15;133(11):1104-14
pubmed: 26976915
J Am Coll Cardiol. 2003 Aug 20;42(4):736-42
pubmed: 12932612
JACC Heart Fail. 2016 Aug;4(8):607-16
pubmed: 27289406
Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S350-70
pubmed: 22588756
J Clin Oncol. 1991 Nov;9(11):2042-51
pubmed: 1941063
Intelligence. 2011 Jul;39(4):222-232
pubmed: 21789028
Circulation. 2010 Jul 13;122(2):191-225
pubmed: 20585013
J Clin Oncol. 1997 Mar;15(3):974-86
pubmed: 9060536
Assessment. 2012 Mar;19(1):21-30
pubmed: 22156721
Eur J Heart Fail. 2011 Jan;13(1):18-28
pubmed: 20685685
Eur J Cancer. 2013 Sep;49(13):2900-9
pubmed: 23706982
Res Q Exerc Sport. 1999 Jun;70(2):113-9
pubmed: 10380242
Eur Heart J. 2016 Sep 21;37(36):2768-2801
pubmed: 27567406
Clin Sci (Lond). 2016 Dec 1;130(24):2239-2244
pubmed: 27815508
Am J Cardiol. 2001 Mar 1;87(5):601-5
pubmed: 11230846
Circulation. 2017 Apr 18;135(16):e894-e918
pubmed: 28336790
Eur Radiol. 2014 Jun;24(6):1366-75
pubmed: 24604216
Eur J Heart Fail. 2014 Feb;16(2):180-8
pubmed: 24464981
J Natl Cancer Inst. 2009 Nov 4;101(21):1464-88
pubmed: 19826136
J Clin Oncol. 2011 Oct 20;29(30):4014-21
pubmed: 21911717
J Cachexia Sarcopenia Muscle. 2015 Jun;6(2):115-24
pubmed: 26136187
J Clin Oncol. 2012 Jul 10;30(20):2530-7
pubmed: 22614980
CA Cancer J Clin. 2016 Jan-Feb;66(1):43-73
pubmed: 26641959
Neuropsychol Rehabil. 2018 Sep;28(6):1019-1027
pubmed: 27624393
J Cardiovasc Magn Reson. 2017 Jan 23;19(1):7
pubmed: 28110638
J Natl Cancer Inst. 2015 Nov 23;108(4):
pubmed: 26598513
Arch Clin Neuropsychol. 2006 Oct;21(7):693-703
pubmed: 16987634
J Cardiovasc Magn Reson. 2010 May 11;12:26
pubmed: 20459799
J Clin Oncol. 2007 Oct 1;25(28):4396-404
pubmed: 17785708
Eur Heart J Cardiovasc Imaging. 2014 Oct;15(10):1063-93
pubmed: 25239940
J Am Med Dir Assoc. 2013 Mar;14(3):170-8
pubmed: 23276432
Circulation. 2005 Dec 13;112(24):3738-44
pubmed: 16330684
J Clin Oncol. 2010 Jul 20;28(21):3429-36
pubmed: 20530277
J Am Coll Cardiol. 2009 Jun 16;53(24):2231-47
pubmed: 19520246
JACC Cardiovasc Imaging. 2014 Aug;7(8):824-38
pubmed: 25124015
J Natl Cancer Inst. 2008 Feb 20;100(4):252-60
pubmed: 18270335
Arch Phys Med Rehabil. 2007 May;88(5):604-9
pubmed: 17466729
Eur J Prev Cardiol. 2019 Feb;26(3):305-315
pubmed: 30376366
J Acad Nutr Diet. 2012 Aug;112(8):1134-7
pubmed: 22704899
Lancet Oncol. 2011 Jul;12(7):703-8
pubmed: 21354373
Circ Heart Fail. 2017 Jun;10(6):
pubmed: 28572213
N Engl J Med. 2000 Apr 13;342(15):1077-84
pubmed: 10760308
Circulation. 2019 May 21;139(21):e997-e1012
pubmed: 30955352