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01-12-2020 | Breast Cancer | Study protocol

Eurythmy therapy versus slow movement fitness in the treatment of fatigue in metastatic breast cancer patients: study protocol for a randomized controlled trial

Authors: Delphine Meier-Girard, Karin Ribi, Gisa Gerstenberg, Thomas Ruhstaller, Ursula Wolf

Published in: Trials | Issue 1/2020

Abstract

Background

Cancer-related fatigue (CRF) is the most taxing symptom for many breast cancer patients during and after therapy. In patients with metastatic disease, the prevalence of CRF exceeds 75%. Currently, there is no gold standard for the treatment of CRF. Physical activity can reduce CRF and is recommended during and after cancer treatment, but may be too burdensome for patients with metastatic breast cancer. The aim of this study is to assess the effect on fatigue of eurythmy therapy (ERYT) compared to slow movement fitness (CoordiFit) in metastatic breast cancer patients.

Methods

The ERYT/CoordiFit study is a randomized controlled, open-label, two-arm, multi-center Swiss clinical trial. A sample of 196 patients presenting with CRF will be recruited by oncologists from the departments of clinical oncology at each local study site. All participants will be randomly allocated to the intervention or control group in a 1:1 ratio. The control group is an active control intervention (CoordiFit) in order to control for potential non-intended effects such as therapist-patient interaction and participation in a program. Both ERYT and CoordiFit exercises are easy to learn, and the training sessions will follow the same frequency and duration schedule, i.e., 13 standardized therapy sessions of 45 min (once a week for 6 weeks and then once every second week) during the total intervention period of 20 weeks. The primary endpoint of the study is the change from baseline over the whole intervention period (i.e., including measurements at baseline, weeks 8, 14, and 20) in the Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F) subscale score.

Discussion

This study is the first-known randomized clinical trial assessing eurythmy therapy in the treatment of fatigue in metastatic breast cancer patients. Given the distress that fatigue causes patients, it is important to validate treatment options. If eurythmy therapy proves beneficial in CRF as part of this randomized controlled clinical trial, the study may be very impactful with implications not only for metastatic breast cancer patients but also for other cancer patients, health care personnel, scientists, and funding and regulatory bodies.

Trial registration

The ERYT/CoordiFit trial was registered at the US National Institutes of Health (ClinicalTrials.gov) on July 18, 2019, #NCT04024267, and in the portal for human research in Switzerland on December 3, 2019, #SNCTP000003525.

Cleeland CS, Zhao F, Chang VT, Sloan JA, O'Mara AM, Gilman PB, et al. The symptom burden of cancer: evidence for a core set of cancer-related and treatment-related symptoms from the Eastern Cooperative Oncology Group Symptom Outcomes and Practice Patterns study. Cancer. 2013;119(24):4333–40.PubMed

Bower JE. Cancer-related fatigue--mechanisms, risk factors, and treatments. Nat Rev Clin Oncol. 2014;11(10):597–609.PubMedPubMedCentral

Berger AM, Mooney K, Alvarez-Perez A, Breitbart WS, Carpenter KM, Cella D, et al. Cancer-related fatigue, version 2.2015. J Natl Compr Cancer Netw. 2015;13(8):1012–39.

Eyles C, Leydon GM, Hoffman CJ, Copson ER, Prescott P, Chorozoglou M, et al. Mindfulness for the self-management of fatigue, anxiety, and depression in women with metastatic breast cancer: a mixed methods feasibility study. Integr Cancer Ther. 2015;14(1):42–56.PubMed

Arndt V, Stegmaier C, Ziegler H, Brenner H. A population-based study of the impact of specific symptoms on quality of life in women with breast cancer 1 year after diagnosis. Cancer. 2006;107(10):2496–503.PubMed

Bower JE, Ganz PA, Desmond KA, Rowland JH, Meyerowitz BE, Belin TR. Fatigue in breast cancer survivors: occurrence, correlates, and impact on quality of life. J Clin Oncol. 2000;18(4):743–53.PubMed

Curt GA, Breitbart W, Cella D, Groopman JE, Horning SJ, Itri LM, et al. Impact of cancer-related fatigue on the lives of patients: new findings from the fatigue coalition. Oncologist. 2000;5(5):353–60.PubMed

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.PubMedPubMedCentral

Dagnelie PC, Pijls-Johannesma MC, Lambin P, Beijer S, De Ruysscher D, Kempen GI. Impact of fatigue on overall quality of life in lung and breast cancer patients selected for high-dose radiotherapy. Ann Oncol. 2007;18(5):940–4.PubMed

10.

Neefjes EC, van der Vorst MJ, Blauwhoff-Buskermolen S, Verheul HM. Aiming for a better understanding and management of cancer-related fatigue. Oncologist. 2013;18(10):1135–43.PubMedPubMedCentral

11.

Greenlee H, DuPont-Reyes MJ, Balneaves LG, Carlson LE, Cohen MR, Deng G, et al. Clinical practice guidelines on the evidence-based use of integrative therapies during and after breast cancer treatment. CA Cancer J Clin. 2017;67(3):194–232.PubMedPubMedCentral

12.

Guidelines N. Cancer-related fatigue, version 2.2018 2018 [https://oncolife.com.ua/doc/nccn/fatigue.pdf]. Accessed 29 June 2020.

13.

Bower JE, Bak K, Berger A, Breitbart W, Escalante CP, Ganz PA, et al. Screening, assessment, and management of fatigue in adult survivors of cancer: an American Society of Clinical oncology clinical practice guideline adaptation. J Clin Oncol. 2014;32(17):1840–50.PubMedPubMedCentral

14.

Mustian KM, Alfano CM, Heckler C, Kleckner AS, Kleckner IR, Leach CR, et al. Comparison of pharmaceutical, psychological, and exercise treatments for cancer-related fatigue: a meta-analysis. JAMA Oncol. 2017;3(7):961–8.PubMedPubMedCentral

15.

Minton O, Richardson A, Sharpe M, Hotopf M, Stone P. Drug therapy for the management of cancer-related fatigue. Cochrane Database Syst Rev. 2010;7:CD006704.

16.

Bower JE, Garet D, Sternlieb B, Ganz PA, Irwin MR, Olmstead R, et al. Yoga for persistent fatigue in breast cancer survivors: a randomized controlled trial. Cancer. 2012;118(15):3766–75.PubMed

17.

Deng G, Chan Y, Sjoberg D, Vickers A, Yeung KS, Kris M, et al. Acupuncture for the treatment of post-chemotherapy chronic fatigue: a randomized, blinded, sham-controlled trial. Support Care Cancer. 2013;21(6):1735–41.PubMedPubMedCentral

18.

Gielissen MF, Verhagen CA, Bleijenberg G. Cognitive behaviour therapy for fatigued cancer survivors: long-term follow-up. Br J Cancer. 2007;97(5):612–8.PubMedPubMedCentral

19.

Gielissen MF, Verhagen S, Witjes F, Bleijenberg G. Effects of cognitive behavior therapy in severely fatigued disease-free cancer patients compared with patients waiting for cognitive behavior therapy: a randomized controlled trial. J Clin Oncol. 2006;24(30):4882–7.PubMed

20.

Jain S, Pavlik D, Distefan J, Bruyere RL, Acer J, Garcia R, et al. Complementary medicine for fatigue and cortisol variability in breast cancer survivors: a randomized controlled trial. Cancer. 2012;118(3):777–87.PubMed

21.

Molassiotis A, Sylt P, Diggins H. The management of cancer-related fatigue after chemotherapy with acupuncture and acupressure: a randomised controlled trial. Complement Ther Med. 2007;15(4):228–37.PubMed

22.

Molassiotis A, Bardy J, Finnegan-John J, Mackereth P, Ryder DW, Filshie J, et al. Acupuncture for cancer-related fatigue in patients with breast cancer: a pragmatic randomized controlled trial. J Clin Oncol. 2012;30(36):4470–6.PubMed

23.

van der Lee ML, Garssen B. Mindfulness-based cognitive therapy reduces chronic cancer-related fatigue: a treatment study. Psychooncology. 2012;21(3):264–72.PubMed

24.

Yun YH, Lee KS, Kim YW, Park SY, Lee ES, Noh DY, et al. Web-based tailored education program for disease-free cancer survivors with cancer-related fatigue: a randomized controlled trial. J Clin Oncol. 2012;30(12):1296–303.PubMed

25.

Kiecolt-Glaser JK, Bennett JM, Andridge R, Peng J, Shapiro CL, Malarkey WB, et al. Yoga’s impact on inflammation, mood, and fatigue in breast cancer survivors: a randomized controlled trial. J Clin Oncol. 2014;32(10):1040–9.PubMedPubMedCentral

26.

Kroz M, Fink M, Reif M, Grobbecker S, Zerm R, Quetz M, et al. Multimodal therapy concept and aerobic training in breast cancer patients with chronic cancer-related fatigue. Integr Cancer Ther. 2013;12(4):301–11.PubMed

27.

Pearson EJM, Morris ME, di Stefano M, McKinstry CE. Interventions for cancer-related fatigue: a scoping review. Eur J Cancer Care (Engl). 2018;27(1):1-14.

28.

Langerhorst U, Petersen P. Ihre Wirkung und Ihre wissenschaftliche Bewertung. Stuttgart: Urachhaus; 1999.

29.

Kirchner-Bockholt M. Grundelement der Heil-Eurythmie. Berlin: Goetheanum; 2010.

30.

Steiner R. Curative eurythmy. Dornach: Press RS; 1983.

31.

Kienle GS, Kiene H, Albonico HU. Anthroposophic medicine: health technology assessment report - short version. Forsch Komplementmed. 2006;13 Suppl 2:7–18.PubMed

32.

von Laue H, von Laue E. The physiology of therapeutic eurythmy. Edinburg: Book F; 2010.

33.

Kanitz JL, Pretzer K, Reif M, Witt K, Reulecke S, Voss A, et al. The impact of eurythmy therapy on fatigue in healthy adults. A controlled trial. European Journal of Integrative Medicine. 2012;4(3):e289–e97.

34.

Wolsko PM, Eisenberg DM, Davis RB, Phillips RS. Use of mind-body medical therapies. J Gen Intern Med. 2004;19(1):43–50.PubMedPubMedCentral

35.

Sparber A, Wootton JC. Surveys of complementary and alternative medicine: part II. Use of alternative and complementary cancer therapies. J Altern Complement Med. 2001;7(3):281–7.PubMed

36.

Gregoire C, Bragard I, Jerusalem G, Etienne AM, Coucke P, Dupuis G, et al. Group interventions to reduce emotional distress and fatigue in breast cancer patients: a 9-month follow-up pragmatic trial. Br J Cancer. 2017;117(10):1442–9.PubMedPubMedCentral

37.

Arun B, Austin T, Babiera GV, Basen-Engquist K, Carmack CL, Chaoul A, et al. A comprehensive lifestyle randomized clinical trial: design and initial patient experience. Integr Cancer Ther. 2017;16(1):3–20.PubMed

38.

Horneber M, Bueschel G, Dennert G, Less D, Ritter E, Zwahlen M. How many cancer patients use complementary and alternative medicine: a systematic review and metaanalysis. Integr Cancer Ther. 2012;11(3):187–203.PubMed

39.

Clarke TC. The use of complementary health approaches among U.S. adults with a recent cancer diagnosis. J Altern Complement Med. 2018;24(2):139–45.PubMed

40.

Kanitz JL, Pretzer K, Reif M, Voss A, Brand R, Warschburger P, et al. The impact of eurythmy therapy on stress coping strategies and health-related quality of life in healthy, moderately stressed adults. Complement Ther Med. 2011;19(5):247–55.PubMed

41.

Berger B, Bertram M, Kanitz J, Pretzer K, Seifert G. “Like walking into an empty room”: effects of eurythmy therapy on stress perception in comparison with a sports intervention from the subjects' perspective-a qualitative study. Evid Based Complement Alternat Med. 2015;2015:856107.PubMedPubMedCentral

42.

Bussing A, Poier D, Ostermann T, Kroz M, Michalsen A. Treatment of chronic lower back pain: study protocol of a comparative effectiveness study on yoga, eurythmy therapy, and physiotherapeutic exercises. Complement Med Res. 2018;25(1):24–9.PubMed

43.

Ernst E. Eurythmy calms the hyperactive child. MMW Fortschr Med. 2004;146(13):27.PubMed

44.

Kanitz JL, Pretzer K, Calaminus G, Wiener A, Langler A, Henze G, et al. Eurythmy therapy in the aftercare of pediatric posterior fossa tumour survivors--a pilot study. Complement Ther Med. 2013;21(Suppl 1):S3–9.PubMed

45.

Kienle GS, Hampton Schwab J, Murphy JB, Andersson P, Lunde G, Kiene H, et al. Eurythmy therapy in anxiety. Altern Ther Health Med. 2011;17(4):56–63.PubMed

46.

Majorek M, Tuchelmann T, Heusser P. Therapeutic Eurythmy-movement therapy for children with attention deficit hyperactivity disorder (ADHD): a pilot study. Complement Ther Nurs Midwifery. 2004;10(1):46–53.PubMed

47.

Zerm R, Lutnaes-Mast F, Mast H, Girke M, Kroz M. Effects of eurythmy therapy in the treatment of essential arterial hypertension: a pilot study. Glob Adv Health Med. 2013;2(1):24–30.PubMedPubMedCentral

48.

Hamre HJ, Witt CM, Glockmann A, Ziegler R, Willich SN, Kiene H. Eurythmy therapy in chronic disease: a four-year prospective cohort study. BMC Public Health. 2007;7:61.PubMedPubMedCentral

49.

Bussing A, Ostermann T, Majorek M, Matthiessen PF. Eurythmy therapy in clinical studies: a systematic literature review. BMC Complement Altern Med. 2008;8:8.PubMedPubMedCentral

50.

Lotzke D, Heusser P, Bussing A. A systematic literature review on the effectiveness of eurythmy therapy. J Integr Med. 2015;13(4):217–30.PubMed

51.

Chang RY, Koo M, Yu ZR, Kan CB, Chu IT, Hsu CT, et al. The effect of t'ai chi exercise on autonomic nervous function of patients with coronary artery disease. J Altern Complement Med. 2008;14(9):1107–13.PubMed

52.

Lee MS, Kim MK, Lee YH. Effects of qi-therapy (external qigong) on cardiac autonomic tone: a randomized placebo controlled study. Int J Neurosci. 2005;115(9):1345–50.PubMed

53.

Lee MS, Rim YH, Jeong DM, Kim MK, Joo MC, Shin SH. Nonlinear analysis of heart rate variability during qi therapy (external qigong). Am J Chin Med. 2005;33(4):579–88.PubMed

54.

Zhou W, Wan YH, Chen Q, Qiu YR, Luo XM. Effects of tai chi exercise on cancer-related fatigue in patients with nasopharyngeal carcinoma undergoing chemoradiotherapy: a randomized controlled trial. J Pain Symptom Manag. 2018;55(3):737–44.

55.

Lee YH, Lai GM, Lee DC, Tsai Lai LJ, Chang YP. Promoting physical and psychological rehabilitation activities and evaluating potential links among cancer-related fatigue, fear of recurrence, quality of life, and physiological indicators in cancer survivors. Integr Cancer Ther. 2018;17(4):1183–94.PubMedPubMedCentral

56.

Seifert G, Driever PH, Pretzer K, Edelhauser F, Bach S, Laue HB, et al. Effects of complementary eurythmy therapy on heart rate variability. Complement Ther Med. 2009;17(3):161–7.PubMed

57.

Seifert G, Kanitz JL, Pretzer K, Henze G, Witt K, Reulecke S, et al. Improvement of heart rate variability by eurythmy therapy after a 6-week eurythmy therapy training. Integr Cancer Ther. 2012;11(2):111–9.PubMed

58.

Seifert G, Kanitz JL, Pretzer K, Henze G, Witt K, Reulecke S, et al. Improvement of circadian rhythm of heart rate variability by eurythmy therapy training. Evid Based Complement Alternat Med. 2013;2013:564340.PubMedPubMedCentral

59.

Edelhauser F, Minnerop A, Trapp B, Bussing A, Cysarz D. Eurythmy therapy increases specific oscillations of heart rate variability. BMC Complement Altern Med. 2015;15:167.PubMedPubMedCentral

60.

Cella D, Eton DT, Lai JS, Peterman AH, Merkel DE. Combining anchor and distribution-based methods to derive minimal clinically important differences on the Functional Assessment of Cancer Therapy (FACT) anemia and fatigue scales. J Pain Symptom Manag. 2002;24(6):547–61.

61.

Cella D. Manual of the functional assessment of chronic illness therapy (FACIT) measurement system: center on outcomes, research and education (CORE); 1997.

62.

Webster K, Cella D, Yost K. The Functional Assessment of Chronic Illness Therapy (FACIT) measurement system: properties, applications, and interpretation. Health Qual Life Outcomes. 2003;1:79.PubMedPubMedCentral

63.

Luckett T, King MT, Butow PN, Oguchi M, Rankin N, Price MA, et al. Choosing between the EORTC QLQ-C30 and FACT-G for measuring health-related quality of life in cancer clinical research: issues, evidence and recommendations. Ann Oncol. 2011;22(10):2179–90.PubMed

64.

Yellen SB, Cella DF, Webster K, Blendowski C, Kaplan E. Measuring fatigue and other anemia-related symptoms with the Functional Assessment of Cancer Therapy (FACT) measurement system. J Pain Symptom Manag. 1997;13(2):63–74.

65.

Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989;28(2):193–213.PubMed

66.

Mollayeva T, Thurairajah P, Burton K, Mollayeva S, Shapiro CM, Colantonio A. The Pittsburgh sleep quality index as a screening tool for sleep dysfunction in clinical and non-clinical samples: a systematic review and meta-analysis. Sleep Med Rev. 2016;25:52–73.PubMed

67.

Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary care evaluation of mental disorders. Patient health questionnaire. JAMA. 1999;282(18):1737–44.PubMed

68.

Spitzer RL, Williams JB, Kroenke K, Hornyak R, McMurray J. Validity and utility of the PRIME-MD patient health questionnaire in assessment of 3000 obstetric-gynecologic patients: the PRIME-MD patient health questionnaire obstetrics-gynecology study. Am J Obstet Gynecol. 2000;183(3):759–69.PubMed

69.

Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006;166(10):1092–7.PubMed

70.

Cleeland CS, Ryan KM. Pain assessment: global use of the brief pain inventory. Ann Acad Med Singap. 1994;23(2):129–38.PubMed

71.

Atkinson TM, Mendoza TR, Sit L, Passik S, Scher HI, Cleeland C, et al. The brief pain inventory and its “pain at its worst in the last 24 hours” item: clinical trial endpoint considerations. Pain Med. 2010;11(3):337–46.PubMed

72.

National Comprehensive Cancer Network [Available from: https://www.nccn.org. Accessed 29 June 2020.

73.

Martin L, Watanabe S, Fainsinger R, Lau F, Ghosh S, Quan H, et al. Prognostic factors in patients with advanced cancer: use of the patient-generated subjective global assessment in survival prediction. J Clin Oncol. 2010;28(28):4376–83.PubMed

74.

Jager-Wittenaar H, Ottery FD. Assessing nutritional status in cancer: role of the Patient-Generated Subjective Global Assessment. Curr Opin Clin Nutr Metab Care. 2017;20(5):322–9.PubMed

75.

Kroz M, Reif M, Glinz A, Berger B, Nikolaou A, Zerm R, et al. Impact of a combined multimodal-aerobic and multimodal intervention compared to standard aerobic treatment in breast cancer survivors with chronic cancer-related fatigue - results of a three-armed pragmatic trial in a comprehensive cohort design. BMC Cancer. 2017;17(1):166.PubMedPubMedCentral

76.

Kanitz JL, Camus ME, Seifert G. Keeping the balance--an overview of mind-body therapies in pediatric oncology. Complement Ther Med. 2013;21(Suppl 1):S20–5.PubMed

77.

Brunner E, Domhof S, Langer F. Nonparametric analysis of longitudinal data in factorial experiments; 2002.

78.

R Core Team. R: A language and environment for statistical computing. Vienna: R Foundation for Statistical Computing; 2018.

Title: Eurythmy therapy versus slow movement fitness in the treatment of fatigue in metastatic breast cancer patients: study protocol for a randomized controlled trial
Authors: Delphine Meier-Girard
Karin Ribi
Gisa Gerstenberg
Thomas Ruhstaller
Ursula Wolf
Publication date: 01-12-2020
Publisher: BioMed Central
Keywords: Breast Cancer
Breast Cancer
Cancer Fatigue
Fatigue
Published in: Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-020-04542-5

Keynote webinar | Spotlight on sleep in brain health

Springer Medicine

Eurythmy therapy versus slow movement fitness in the treatment of fatigue in metastatic breast cancer patients: study protocol for a randomized controlled trial

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on sleep in brain health

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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