Effects of exercise training programs on physical performance and quality of life in patients with metastatic lung cancer undergoing palliative chemotherapy--a study protocol.

Purpose: The aims of the study protocol are to investigate different adapted physical training programs in patients with advanced lung cancer undergoing palliative chemo- or radiotherapy and to evaluate their effects on physical performance, quality of life, symptom burden, and efficacy of oncologic treatment.

Methods: Patients will be randomized into three study arms: interventional group 1 performing aerobic exercise, interventional group 2 performing resistance training, and a control group without specific physical training. Interventional training will be performed for 12 weeks consisting of two supervised and one self-instructed training sessions per week each. Respiratory therapy over 12 weeks is provided in all three study arms as an established supportive therapy in lung cancer patients. Primary efficacy endpoint is physical performance measured by peak oxygen consumption (VO(2)peak). Secondary efficacy endpoints include additional parameters of physical performance (resistance, lung function, perceived exertion, level of physical activity and IPAQ-questionnaire), health-related quality of life (EORTC QLQ C30-questionnaire), disease and treatment related symptoms (Memorial Symptom Assessment Scale), biologic parameter (e.g. body composition, blood values of immune system, chronic inflammation, glucose and lipid metabolisms), and parameter of efficacy of oncologic treatment.

Discussion: The results of this study will offer an overview over possible effects of specific training interventions on health related quality of life, physical and psychological symptoms, and on the efficacy of oncologic treatment. The primary aim of this study is to detect adapted intervention programs for metastatic lung cancer undergoing palliative chemotherapy.