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Physical Activity and Progressive Muscle Relaxation as Adjuvant Treatment against Cancer-related Fatigue ("Bewegung und Entspannung als Therapie gegen Erschöpfung", BEATE)

In cooperation with the Unit of Environmental Epidemiology at the DKFZ, the Women’s Hospital of the University Clinic of Heidelberg, the Central Institute of Mental Health (CIMH), and the German Sport University (Cologne)
(PIs: Karen Steindorf/formerly Holger Krakowski-Roosen; study coordinators: Martina Schmidt & Joachim Wiskemann)

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 multicenter 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. Recruitment has begun in March 2010 and is estimated to be completed in Summer 2011. During that time 160 patients will be recruited (80 Heidelberg / 80 Cologne). All participants are 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 will be collected for multiple biomarker analyses (CRP, SAA, prostaglandins, cortisol and DNA-repair capacity). Data collection will be performed at baseline, week 7, week 13 and week 26. The interventions start after baseline assessment and will end after 24 sessions (2x/week) at week 13. Randomization will be performed stratified for age and baseline fatigue levels.

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