BEST - Study
Progressive Resistance Training and Progressive Muscle Relaxation during Radiotherapy as Adjuvant Treatment against Cancer-related Fatigue
In cooperation with the Department of Radiation Oncology (Heidelberg University Hospital) and the Istitute of Sports and Sport Science (Heidelberg University).
Principal investigators:
Prof. Dr. Karen Steindorf, Prof. Dr. Cornelia Ulrich, Dr. Robert Owen, Prof. Dr. Philipp Beckhove, Dr. Karin Potthoff, PD Dr. Holger Hof
Co-Principal investigators:
Dr. Martina Schmidt, PD Dr. Joachim Wiskemann
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. However, little is known about the effects of exercise and its biological mechanisms in cancer patients during radio-therapy. Further, 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. Thus, the BEST study was designed to evaluate the potential benefits of progressive resistance training beyond group-related psychosocial effects and to evaluate potential biologic mechanisms.
BEST was 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 radiotherapy, compared with a Progressive Muscle Relaxation (PMR) program. Recruitment has begun in February 2011 and was completed at the end of April 2013. During that time 160 patients were enrolled. 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 will be assessed. Furthermore, blood, urine and saliva samples were collected for multiple analyses of immunological and inflammatory parameters and other biomarkers (IL-6, CRP, SAA, T-regulatory cells, prostaglandins, cortisol and DNA-repair capacity). The interventions started in parallel with the radiotherapy and ended after 24 sessions (2x/week) at week 13. Randomization was performed stratified for age and baseline fatigue levels. Data collection was performed at baseline (which is before start of radiotherapy), at end of radiotherapy, end of 12-week intervention, 3 months after end of radiotherapy, and 6 and 12 months after end of intervention. Currently, the last follow-up assessments are running.
Contact
Prof. Dr. Karen Steindorf
Phone: +49 6221 42-2351
E-mail: karen.steindorf(at)nct-heidelberg.de
Publications
- Schmidt ME, Meyenköhn A, Habermann N, Wiskemann J, Oelmann J, Hof H, Wessels S, Klassen O, Debus J, Potthoff K, Steindorf K, Ulrich CM (2016): Resistance exercise and inflammation in breast cancer patients undergoing adjuvant radiotherapy: Mediation analysis from a randomized controlled intervention trial. International Journal of Radiation Oncology, Biology, Physics 94:329-37
- Wiskemann J, Schmidt ME, Klassen O, Ulrich CM, Potthoff K, Steindorf K (2016). Effects of 12-week resistance training during radiotherapy on isokinetic and isometric muscle strength in breast cancer patients. Scand J Med Sci Sports [Epub Oct 5]
- 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)
- Gollhofer S, Wiskemann J, Schmidt ME, Klassen O, Ulrich CM, Oelmann J, Hof H, Potthoff K, Steindorf K (2015): Factors influencing participation in a randomized controlled resistance exercise intervention study in breast cancer patients during radiotherapy. BMC Cancer. 27;15:186 [Epub Mar 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]
- 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.
- Steindorf K*, Schmidt ME*, Klassen O, Ulrich CM, Oelmann J, Habermann N, Beckhove P, Owen R, Debus J, Wiskemann J, Potthoff K (2014): Randomized Controlled Trial of Resistance Training in Breast Cancer Patients Receiving Adjuvant Radiotherapy: Results on Cancer-related Fatigue and Quality of Life. Ann Oncol. 25:2237-43 [Epub Aug 2014]
* shared first authorship
- Potthoff K*, Schmidt ME*, Wiskemann J, Hof H, Klassen O, Habermann N, Beckhove P, Debus J, Ulrich CM, Steindorf K (2013): Randomized controlled trial to evaluate the effects of progressive resistance training compared to progressive muscle relaxation in breast cancer patients undergoing adjuvant radiotherapy: the BEST study. BMC Cancer, 13:162 doi:10.1186/1471-2407-13-162 * shared first authorship