Jensen Wiebke, Oechsle Karin, Baumann Hans Jörg, Mehnert Anja, Klose Hans, Bloch Wilhelm, Bokemeyer Carsten, Baumann Freerk T
Department of Oncology/Hematology/Bone marrow Transplantation/Pneumology, University Medical Center Eppendorf, Hamburg, Germany.
Department of Oncology/Hematology/Bone marrow Transplantation/Pneumology, University Medical Center Eppendorf, Hamburg, Germany.
Contemp Clin Trials. 2014 Jan;37(1):120-8. doi: 10.1016/j.cct.2013.11.013. Epub 2013 Dec 5.
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.
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.
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.
本研究方案的目的是调查晚期肺癌患者在接受姑息性化疗或放疗时不同的适应性体育训练方案,并评估其对身体机能、生活质量、症状负担和肿瘤治疗疗效的影响。
患者将被随机分为三个研究组:干预组1进行有氧运动,干预组2进行抗阻训练,以及一个不进行特定体育训练的对照组。干预训练将持续12周,每周包括两次有监督的训练课程和一次自我指导的训练课程。在所有三个研究组中,均提供为期12周的呼吸治疗,作为肺癌患者既定的支持性治疗。主要疗效终点是通过峰值耗氧量(VO₂峰值)测量的身体机能。次要疗效终点包括身体机能的其他参数(耐力、肺功能、主观用力感觉、身体活动水平和国际体力活动问卷)、健康相关生活质量(欧洲癌症研究与治疗组织QLQ C30问卷)、疾病和治疗相关症状(纪念症状评估量表)、生物学参数(如身体成分、免疫系统血液值、慢性炎症、葡萄糖和脂质代谢)以及肿瘤治疗疗效参数。
本研究结果将概述特定训练干预对健康相关生活质量、身体和心理症状以及肿瘤治疗疗效的可能影响。本研究的主要目的是为接受姑息性化疗的转移性肺癌患者检测适应性干预方案。