Optitrain: a randomised controlled exercise trial for women with breast cancer undergoing chemotherapy

Y Wengström, K A Bolam, S Mijwel, C J Sundberg, M Backman, M Browall, J Norrbom, H Rundqvist, Y Wengström, K A Bolam, S Mijwel, C J Sundberg, M Backman, M Browall, J Norrbom, H Rundqvist

Abstract

Background: Women with breast cancer undergoing chemotherapy suffer from a range of detrimental disease and treatment related side-effects. Exercise has shown to be able to counter some of these side-effects and improve physical function as well as quality of life. The primary aim of the study is to investigate and compare the effects of two different exercise regimens on the primary outcome cancer-related fatigue and the secondary outcomes muscle strength, function and structure, cardiovascular fitness, systemic inflammation, skeletal muscle gene activity, health related quality of life, pain, disease and treatment-related symptoms in women with breast cancer receiving chemotherapy. The second aim is to examine if any effects are sustained 1, 2, and 5 years following the completion of the intervention and to monitor return to work, recurrence and survival. The third aim of the study is to examine the effect of attendance and adherence rates on the effects of the exercise programme.

Methods: This study is a randomised controlled trial including 240 women with breast cancer receiving chemotherapy in Stockholm, Sweden. The participants are randomly allocated to either: group 1: Aerobic training, group 2: Combined resistance and aerobic training, or group 3: usual care (control group). During the 5-year follow-up period, participants in the exercise groups will receive a physical activity prescription. Measurements for endpoints will take place at baseline, after 16 weeks (end of intervention) as well as after 1, 2 and 5 years.

Discussion: This randomised controlled trial will generate substantial information regarding the effects of different types of exercise on the health of patients with breast cancer undergoing chemotherapy. We expect that dissemination of the knowledge gained from this study will contribute to developing effective long term strategies to improve the physical and psychosocial health of breast cancer survivors.

Trial registration: OptiTrain - Optimal Training Women with Breast Cancer (OptiTrain), NCT02522260 ; Registration: June 9, 2015, Last updated version Feb 29, 2016. Retrospectively registered.

Keywords: Chemotherapy; Exercise intervention; Fatigue; Inflammation; Patients with breast cancer; Skeletal muscle.

Figures

Fig. 1
Fig. 1
The modified SPIRIT study flow chart

References

    1. Newton RU, Galvao DA. Exercise in prevention and management of cancer. Curr Treat Options Oncol. 2008;9(2–3):135–46. doi: 10.1007/s11864-008-0065-1.
    1. Berger AM, Mooney K, Alvarez-Perez A, Breitbart WS, Carpenter KM, Cella D, Cleeland C, Dotan E, Eisenberger MA, Escalante CP, et al. Cancer-related fatigue, version 2.2015. J Nat Compr Canc Netw. 2015;13(8):1012–39.
    1. LaVoy EC, Fagundes CP, Dantzer R. Exercise, inflammation, and fatigue in cancer survivors. Exerc Immunol Rev. 2016;22:82–93.
    1. Velthuis MJ, Agasi-Idenburg SC, Aufdemkampe G, Wittink HM. The effect of physical exercise on cancer-related fatigue during cancer treatment: a meta-analysis of randomised controlled trials. J Clin Oncol. 2010;22(3):208–21. doi: 10.1016/j.clon.2009.12.005.
    1. Schmidt ME, Wiskemann J, Armbrust P, Schneeweiss A, Ulrich CM, Steindorf K. Effects of resistance exercise on fatigue and quality of life in breast cancer patients undergoing adjuvant chemotherapy: a randomized controlled trial. Int J Cancer. 2015;137(2):471–80. doi: 10.1002/ijc.29383.
    1. Meneses-Echavez JF, Gonzalez-Jimenez E, Ramirez-Velez R. Effects of supervised multimodal exercise interventions on cancer-related fatigue: systematic review and meta-analysis of randomized controlled trials. BioMed Res Int. 2015;2015:328636. doi: 10.1155/2015/328636.
    1. Mishra SI, Scherer RW, Geigle PM, Berlanstein DR, Topaloglu O, Gotay CC, Snyder C. Exercise interventions on health-related quality of life for cancer survivors. Cochrane Database Syst Rev (Online) 2012;8:CD007566.
    1. Lee IM, Shiroma EJ, Lobelo F, Puska P, Blair SN, Katzmarzyk PT. Effect of physical inactivity on major non-communicable diseases worldwide: an analysis of burden of disease and life expectancy. Lancet. 2012;380(9838):219–29. doi: 10.1016/S0140-6736(12)61031-9.
    1. Hartvig P, Aulin J, Wallenberg S, Wagenius G. Physical exercise for cytotoxic drug-induced fatigue. J Oncol Pharm Pract. 2006;12(4):183–91. doi: 10.1177/1078155206070776.
    1. Chlebowski RT, Aiello E, McTiernan A. Weight loss in breast cancer patient management. J Clin Oncol. 2002;20(4):1128–43. doi: 10.1200/JCO.20.4.1128.
    1. Montazeri A. Health-related quality of life in breast cancer patients: a bibliographic review of the literature from 1974 to 2007. J Exp Clin Cancer Res. 2008;27:32. doi: 10.1186/1756-9966-27-32.
    1. Cuzick J, Sestak I, Baum M, Buzdar A, Howell A, Dowsett M, Forbes JF. Effect of anastrozole and tamoxifen as adjuvant treatment for early-stage breast cancer: 10-year analysis of the ATAC trial. Lancet Oncol. 2010;11(12):1135–41. doi: 10.1016/S1470-2045(10)70257-6.
    1. Gilliam LA, St Clair DK. Chemotherapy-induced weakness and fatigue in skeletal muscle: the role of oxidative stress. Antioxid Redox Signal. 2011;15(9):2543–63. doi: 10.1089/ars.2011.3965.
    1. Markes M, Brockow T, Resch KL. Exercise for women receiving adjuvant therapy for breast cancer. Cochrane Database Syst Rev. 2006;4:CD005001.
    1. Schmitz KH, Courneya KS, Matthews C, Demark-Wahnefried W, Galvao DA, Pinto BM, Irwin ML, Wolin KY, Segal RJ, Lucia A, et al. American College of Sports Medicine roundtable on exercise guidelines for cancer survivors. Med Sci Sports Exerc. 2010;42(7):1409–26. doi: 10.1249/MSS.0b013e3181e0c112.
    1. Jones LW, Alfano CM. Exercise-oncology research: past, present, and future. Acta Oncol. 2013;52(2):195–215. doi: 10.3109/0284186X.2012.742564.
    1. Kiasuwa Mbengi R, Otter R, Mortelmans K, Arbyn M, Van Oyen H, Bouland C, de Brouwer C. Barriers and opportunities for return-to-work of cancer survivors: time for action-rapid review and expert consultation. Syst Rev. 2016;5(1):35. doi: 10.1186/s13643-016-0210-z.
    1. van Waart H, Stuiver MM, van Harten WH, Geleijn E, Kieffer JM, Buffart LM, de Maaker-Berkhof M, Boven E, Schrama J, Geenen MM, et al. Effect of low-intensity physical activity and moderate- to high-intensity physical exercise during adjuvant chemotherapy on physical fitness, fatigue, and chemotherapy completion rates: results of the PACES randomized clinical trial. J Clin Oncol. 2015;33(17):1918–27. doi: 10.1200/JCO.2014.59.1081.
    1. Murphy EA, Enos RT, Velazquez KT. Influence of exercise on inflammation in cancer: direct effect or innocent bystander? Exerc Sport Sci Rev. 2015;43(3):134–42. doi: 10.1249/JES.0000000000000054.
    1. Hwang JE, Kim HN, Kim DE, Choi HJ, Jung SH, Shim HJ, Bae WK, Hwang EC, Cho SH, Chung IJ. Prognostic significance of a systemic inflammatory response in patients receiving first-line palliative chemotherapy for recurred or metastatic gastric cancer. BMC Cancer. 2011;11:489. doi: 10.1186/1471-2407-11-489.
    1. Gleeson M, Bishop NC, Stensel DJ, Lindley MR, Mastana SS, Nimmo MA. The anti-inflammatory effects of exercise: mechanisms and implications for the prevention and treatment of disease. Nat Rev Immunol. 2011;11(9):607–15. doi: 10.1038/nri3041.
    1. Strandberg E, Edholm P, Ponsot E, Wahlin-Larsson B, Hellmen E, Nilsson A, Engfeldt P, Cederholm T, Riserus U, Kadi F. Influence of combined resistance training and healthy diet on muscle mass in healthy elderly women: a randomized controlled trial. J Appl Physiol (1985) 2015;119(8):918–25. doi: 10.1152/japplphysiol.00066.2015.
    1. Jones LW, Fels DR, West M, Allen JD, Broadwater G, Barry WT, Wilke LG, Masko E, Douglas PS, Dash RC, et al. Modulation of circulating angiogenic factors and tumor biology by aerobic training in breast cancer patients receiving neoadjuvant chemotherapy. Cancer Prev Res (Phila) 2013;6(9):925–37. doi: 10.1158/1940-6207.CAPR-12-0416.
    1. Glass OK, Inman BA, Broadwater G, Courneya KS, Mackey JR, Goruk S, Nelson ER, Jasper J, Field CJ, Bain JR, et al. Effect of aerobic training on the host systemic milieu in patients with solid tumours: an exploratory correlative study. Br J Cancer. 2015;112(5):825–31. doi: 10.1038/bjc.2014.662.
    1. Koelwyn GJ, Wennerberg E, Demaria S, Jones LW. Exercise in regulation of inflammation-immune axis function in cancer initiation and progression. Oncology (Williston Park). 2015;29(12):214800.
    1. Piper BF. Piper fatigue scale available for clinical testing. Oncol Nurs Forum. 1990;17(5):661–2.
    1. Jakobsson S, Taft C, Ostlund U, Ahlberg K. Performance of the Swedish version of the revised Piper Fatigue Scale. Eur J Oncol Nurs. 2013;17(6):808–13. doi: 10.1016/j.ejon.2013.07.004.
    1. Bergstrom J. Percutaneous needle biopsy of skeletal muscle in physiological and clinical research. Scand J Clin Lab Invest. 1975;35(7):609–16. doi: 10.3109/00365517509095787.
    1. Portenoy RK, Thaler HT, Kornblith AB, Lepore JM, Friedlander-Klar H, Kiyasu E, Sobel K, Coyle N, Kemeny N, Norton L, et al. The Memorial Symptom Assessment Scale: an instrument for the evaluation of symptom prevalence, characteristics and distress. Eur J Cancer. 1994;30A(9):1326–36. doi: 10.1016/0959-8049(94)90182-1.
    1. Browall M, Kenne Sarenmalm E, Nasic S, Wengstrom Y, Gaston-Johansson F. Validity and reliability of the Swedish version of the Memorial Symptom Assessment Scale (MSAS): an instrument for the evaluation of symptom prevalence, characteristics, and distress. J Pain Symptom Manage. 2013;46(1):131–41. doi: 10.1016/j.jpainsymman.2012.07.023.
    1. Langius A, Bjorvell H, Antonovsky A. The sense of coherence concept and its relation to personality traits in Swedish samples. Scand J Caring Sci. 1992;6(3):165–71. doi: 10.1111/j.1471-6712.1992.tb00146.x.
    1. Eriksson M, Lindstrom B. Validity of Antonovsky’s sense of coherence scale: a systematic review. J Epidemiol Community Health. 2005;59(6):460–6. doi: 10.1136/jech.2003.018085.
    1. Troiano RP, Berrigan D, Dodd KW, Masse LC, Tilert T, McDowell M. Physical activity in the United States measured by accelerometer. Med Sci Sports Exerc. 2008;40(1):181–8. doi: 10.1249/mss.0b013e31815a51b3.
    1. Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377–81. doi: 10.1249/00005768-198205000-00012.
    1. Kallings LV, Leijon M, Hellenius ML, Stahle A. Physical activity on prescription in primary health care: a follow-up of physical activity level and quality of life. Scand J Med Sci Sports. 2008;18(2):154–61. doi: 10.1111/j.1600-0838.2007.00678.x.
    1. Courneya KS, McKenzie DC, Mackey JR, Gelmon K, Friedenreich CM, Yasui Y, Reid RD, Cook D, Jespersen D, Proulx C, et al. Effects of exercise dose and type during breast cancer chemotherapy: multicenter randomized trial. J Natl Cancer Inst. 2013;105(23):1821–32. doi: 10.1093/jnci/djt297.
    1. Adamsen L, Quist M, Andersen C, Moller T, Herrstedt J, Kronborg D, Baadsgaard MT, Vistisen K, Midtgaard J, Christiansen B, et al. Effect of a multimodal high intensity exercise intervention in cancer patients undergoing chemotherapy: randomised controlled trial. BMJ. 2009;339:b3410. doi: 10.1136/bmj.b3410.
    1. Schmitt J, Lindner N, Reuss-Borst M, Holmberg HC, Sperlich B. A 3-week multimodal intervention involving high-intensity interval training in female cancer survivors: a randomized controlled trial. Physiol Rep. 2016;4(3):e12693.
    1. Nikander R, Sievanen H, Ojala K, Kellokumpu-Lehtinen PL, Palva T, Blomqvist C, Luoto R, Saarto T. Effect of exercise on bone structural traits, physical performance and body composition in breast cancer patients--a 12-month RCT. J Musculoskelet Neuronal Interact. 2012;12(3):127–35.
    1. Devin JL, Sax AT, Hughes GI, Jenkins DG, Aitken JF, Chambers SK, Dunn JC, Bolam KA, Skinner TL. The influence of high-intensity compared with moderate-intensity exercise training on cardiorespiratory fitness and body composition in colorectal cancer survivors: a randomised controlled trial. J Cancer Surviv. 2016;10(3):467–79.

Source: PubMed

Szponzorok és közreműködők

Egészségi állapot

Kábítószer-beavatkozások

3
Iratkozz fel