Previous exercise trials mostly compared the intervention with ¡®usual care¡¯. Therefore, it is unclear to what extent the observed effects on fatigue are based on physical adaptations by exercise itself, or rather on psycho-social factors linked to the group support or attention by the trainer.
The BEATE study is a randomized, controlled intervention trial comparing a 12-week supervised progressive resistance training program with a supervised group-based progressive muscle relaxation training in 100 patients with breast cancer under adjuvant chemotherapy. The primary endpoint is cancer-related fatigue; secondary endpoints include quality of life, depression, and cognitive capacity. In addition, isokinetic and isometric muscle strength, cardiorespiratory fitness, and body composition are measured, and biomarkers, such as inflammatory parameters, cortisol, and oxidative stress are analyzed in blood, saliva and urine. Safety of the resistance training during chemotherapy is monitored.
Strengths of the BEATE study include the investigation of progressive resistance training parallel with chemotherapy, the choice of a control group that enables an evaluation of the physiological effects of exercise beyond potential psycho-social effects, and the comprehensive and high-quality assessment of physiological factors and biomarkers potentially related to fatigue.