BEATE study

Abstract

Cancer-Related Fatigue (CRF) is a multidimensional syndrome which occurs in the majority of cancer patients during anticancer treatment and potentially persists for many years after cure. Because of its multidimensionality, CRF is influenced by physical, psychological and also social factors. Summarized by an article of the Cochrane Collaboration, exercise is a promising intervention for the treatment of CRF in breast cancer patients, but nearly all studies in this field examined the effect of exercise against treatment-as-usual, mostly in group settings. Therefore, it is currently unknown if the beneficial effects are related to the physical training itself or caused by group-related psychosocial effects.

The BEATE-Study was designed to evaluate the potential benefits of an exercise program beyond group-related psychosocial effects and to evaluate potential biologic mechanisms.
BEATE is a randomized controlled clinical trial, aimed to evaluate the effect of a high intensity, supervised and group-based resistance training on CRF in breast cancer patients during adjuvant chemotherapy, compared with a Progressive Muscle Relaxation (PMR) program.

All participants were requested to fill out standardized questionnaires concerning fatigue, quality of life and depression. In addition, physical performance (endurance and strength capacity), activity history and cognitive capacity were assessed. Furthermore, blood, urine and saliva samples will be collected for multiple biomarker analyses. Data collection was performed at begin of the study (baseline), week 7, week 13 and week 26.  The interventions (2x/week, 24 sessions) started after baseline assessment and ended at week 12. Randomization (allocation in two groups “exercise” and “relaxing”) was performed by a PC program.

Current status

Recruitment has begun in March 2010 and was completed in June 2013 with 101 patients.

Registration

ClinicalTrials.gov (NCT01106820)

Publications

Koeppel M, Steindorf K, Schmidt ME,  Rosenberger F, Wiskemann J (2024): Variability in resistance training trajectories of breast cancer patients undergoing therapy. Supportive Care in Cancer, 33 (1), 12, https://doi.org/10.1007/s00520-024-09001-4

Pal A, Zimmer P, Schmidt ME, Hummels M., Ulrich CM, Wiskemann J, Steindorf K (2019): No evidence for effect of exercise on transcriptome of NK cells in breast cancer patients undergoing adjuvant therapy: Results from a pilot study.  Frontiers in Physiology, 10, 959, https://doi.org/10.3389/fphys.2019.00959

van Vulpen JK, Sweegers MG, Peeters PHM, Courneya KS, Newton RU, Aaronson NK, Jacobsen PB, Galvão DA, Chinapaw MJ, Steindorf K, Irwin ML, Stuiver MM, Hayes S, Griffith KA, Mesters I, Knoop H, Goedendorp MM, Mutrie N, Daley AJ, McConnachie A, Bohus M, Thorsen L, Schulz KH, Short CE, James EL, Plotnikoff RC, Schmidt ME, Ulrich CM, van Beurden M, Oldenburg HS, Sonke GS, van Harten WH, Schmitz KH, Winters-Stone KM, Velthuis MJ, Taaffe DR, van Mechelen W, Kersten MJ, Nollet F, Wenzel J, Wiskemann J, Verdonck-de Leeuw IM, Brug J, May AM, Buffart LM (2019): Moderators of Exercise Effects on Cancer-related Fatigue: A Meta-analysis of Individual Patient Data. Med Sci Sports Exerc, [Epub ahead of print]

Schmidt ME, Scherer S, Wiskemann J, Steindorf K (2019): Return to work after breast cancer: the role of treatment-related side effects and potential impact on quality of life. European Journal of Cancer Care, [Epub ahead of print].

Buffart LM, Sweegers MG, May AM, Chinapaw MJ, van Vulpen J, Newton RU, Galvão DA, Aaronson NK, Stuiver MM, Jacobsen PB, Verdonck-de Leeuw IM, Steindorf K, Irwin ML,  Hayes S, Griffith KA, Lucia A, Mesters I, van Weert E, Knoop H, Goedendorp MM, Mutrie N, Daley AJ, McConnachie A, Bohus M, Thorsen L, Schulz KH, Short CE, James EL, Plotnikoff RC, Arbane G, Schmidt ME, Potthoff K, van Beurden M,  Oldenburg HS, Sonke GS, van Harten WH, Garrod R, Schmitz KH, Winters-Stone KM, Velthuis MJ, Taaffe DR, van Mechelen W, Kersten MJ, Nollet F, Wenzel J, Wiskemann J, Brug J, Courneya KS (2018): Targeting exercise interventions to patients with cancer in need: Results from an individual patient data meta-analysis. Journal of the National Cancer Institute, 110,1190-1200. doi: 10.1093/jnci/djy161.

Sweegers MG, Altenburg TM, Brug J, May AM, van Vulpen JK, Aaronson NK, Arbane G, Bohus M, Courneya KS, Daley AJ, Galvao DA, Garrod R, Griffith KA, van Harten WH, Hayes S, Herrero F, Kersten MJ, Lucia A, McConnachie A, van Mechelen W, Mutrie N,  Newton RU, Nollet F, Potthoff K, Schmidt ME, Schmitz KH, Schulz KH, Sonke GS, Steindorf K,  Stuiver MM, Taaffe DR, Thorsen L, Twisk JW, Velthuis MJ, Wenzel J, Winters-Stone KM,  Wiskemann J, Chin A Paw MJ, Buffart LM (2018): Moderators of the exercise effects on physical fitness in patients with cancer: a meta-analysis of individual patient data. British Journal of Sports Medicine, 53, 812. Epub, doi: 10.1136/bjsports-2018-099191.

Schmidt M, Wiskemann J, Steindorf K (2018): Quality of life, problems, and needs of disease-free breast cancer survivors 5 years after diagnosis. Quality of Life Research, 27, 2077-2086.

Schmidt ME, Wiskemann J, Johnson T, Habermann N, Schneeweiss A, Steindorf K (2018): L-thyroxine intake as a potential risk factor for the development of fatigue in breast cancer patients undergoing chemotherapy. Supportive Care in Cancer, 26, 2561-2569.

van Vulpen JK, Schmidt ME, Velthuis MJ, Wiskemann J, Schneeweiss A, Vermeulen RCH, Habermann N, Ulrich CM, Peeters PHM, van der Wall E, May AM, Steindorf K (2018): Effects of physical exercise on markers of inflammation in breast cancer patients during adjuvant chemotherapy. Breast Cancer Research and Treatment, 168, 421-431.

Schmidt ME, Wiskemann J, Schneeweiss A, Potthoff K, Ulrich CM, Steindorf K (2018): Determinants of physical, affective, and cognitive fatigue during breast cancer therapy and 12 months follow-up. International Journal of Cancer, 142, 1148-1157.

Klassen O, Schmidt ME, Ulrich CM, Schneeweiss A, Potthoff K, Steindorf K, Wiskemann J (2017). Muscle strength in breast cancer patients receiving different treatment regimes. J Cachexia Sarcopenia Muscle 8:305-316.

Buffart, LM, Kalter J, Sweegers MG, Courneya KS, Newton RU, Aaronson NK, Jacobsen PB, May AM, Galvão DA, Chinapaw MJ, Steindorf K, Irwin ML, Stuiver MM, Hayes S, Griffith KA, Lucia A, Mesters I, van Weert E, Knoop H, Goedendorp M, Mutrie N, Daley AJ, McConnachie A, Bohus M, Thorsen L, Schulz K-H, Short CE, James EL, Plotnikoff RC, Arbane G, Schmidt ME, Potthoff K, van Beurden M, Oldenburg HS, Sonke GS, van Harten W, Garrod R, Schmitz KH, Winters KM, Velthuis MJ, Taaffe DR, van Mechelen W, Kersten M-J, Nollet F, Wenzel J, Wiskemann J, Verdonck-de Leeuw IM, Brug J (2017): Effects and moderators of exercise on quality of life and physical function in patients with cancer: an individual patient data metaanalysis of 34 RCTs. Cancer Treat Rev; 52:91-104

Schmidt ME, Wiskemann J, Ulrich CM, Schneeweiss A, Steindorf K (2017). Self-reported physical activity behavior of breast cancer survivors during and after adjuvant therapy: 12 months follow-up of two randomized exercise intervention trials. Acta Oncol 56:618-627

Schmidt ME, Wiskemann J, Schneeweiss A, Potthoff K, Ulrich CM, Steindorf K (2017). Courses and determinants of physical, affective, and cognitive fatigue during breast cancer therapy and 12 months follow-up. Int J Cancer.

van Vulpen JK, Schmidt ME, Velthuis MJ, Wiskemann J, Schneeweiss A, Vermeulen RCH, Habermann N, Ulrich CM, Peeters PHM, van der Wall E, May AM, Steindorf K (2017). Effects of physical exercise on markers of inflammation in breast cancer patients during adjuvant chemotherapy. Breast Cancer Res Treat.

Klassen O, Schmidt ME, Ulrich CM, Potthoff K, Steindorf K, Wiskemann J. Muscle strength in breast cancer patients undergoing adjuvant therapy (accepted by J Cachexia Sarcopenia Muscle, Oct 2016)

Schmidt ME, Semik J, Habermann N, Wiskemann J, Ulrich CM, Steindorf K (2016): Cancer-related fatigue shows a stable association with diurnal cortisol dysregulation in breast cancer patients. Brain Behavior and Immunity 52:98-105 (Epub 0ct 2015)

Scharhag-R F, Kühl R, Klassen O, Schommer K, Schmidt ME, Wiskemann J, Steindorf K (2015): Exercise training intensity prescription in breast cancer survivors: validity of current practice and specific recommendations. J Cancer Surviv, 9:612-9. [Epub Feb 2015]

Schmidt ME, Wiskemann J, Armbrust P, Schneeweiss A, Ulrich CM, Steindorf K (2015): Effects of resistance exercise on fatigue and quality of life in breast cancer patients undergoing adjuvant chemotherapy: a randomized controlled trial. Int J cancer, 137:471-80 [Epub Dec 2014]

Klassen O, Schmidt ME, Scharhag-Rosenberger F, Sorkin M, Ulrich CM, Schneeweiss A, Potthoff K, Steindorf K, Wiskemann J (2014): Cardiorespiratory fitness in breast cancer patients undergoing adjuvant therapy. Acta Oncol. May 16:1-10.

Schmidt ME, Wiskemann J, Krakowski-Roosen H, Knicker A, Habermann N, Schneeweiss A, Ulrich N, Steindorf K(2013): Progressive resistance versus relaxation training for breast cancer patients during adjuvant chemotherapy: Design and rationale of a randomized clinical trial (BEATE study). Contemporary Clinical Trials, 34, 117-125