Efficacy and safety of a modular multi-modal exercise program in prostate cancer patients with bone metastases: a randomized controlled trial

BMC Cancer

Study Protocol

David Joseph¹  Nigel Spry¹  Daniel A Galvão²  Michael Baker²  Carolyn Peddle-McIntyre²  Robert U Newton²  Prue Cormie²  Suzanne K Chambers³  Geoff Groom⁴  Dennis R Taaffe⁵  James Denham⁶ 

[1] Department of Radiation Oncology, Sir Charles Gairdner Hospital, Nedlands, Australia;Faculty of Medicine, University of Western Australia, Nedlands, Australia;Edith Cowan University Health and Wellness Institute and School of Exercise and Health Sciences, Edith Cowan University, Joondalup, Australia;Griffith Health Institute, Griffith University, Gold Coast, Australia;Viertel Centre for Research in Cancer Control, Cancer Council Queensland, Brisbane, Australia;Perth Radiological Clinic, Joondalup Health Campus, Joondalup, Australia;School of Environmental and Life Sciences, University of Newcastle, Ourimbah, Australia;School of Medicine and Public Health, University of Newcastle, Newcastle, Australia;Newcastle Mater Hospital, Newcastle, Australia;

关键词: Prostate Cancer;    Bone Metastasis;    Androgen Deprivation Therapy;    Prostate Cancer Patient;    Pittsburgh Sleep Quality Index;   

DOI  :  10.1186/1471-2407-11-517

 received in 2011-11-22, accepted in 2011-12-13,  发布年份 2011

来源: Springer

【 摘 要 】

BackgroundThe presence of bone metastases has excluded participation of prostate cancer patients in exercise intervention studies to date and is also a relative contraindication to supervised exercise in the community setting because of concerns of fragility fracture. However, this group of patients often have developed significant muscle atrophy and functional impairments from prior and continuing androgen deprivation that is exacerbated by subsequent and more intensive interventions such as chemotherapy. The aim of this study is to determine the efficacy and safety of a modular multi-modal exercise program in prostate cancer patients with bone metastases.Methods/DesignMulti-site randomized controlled trial in Western Australia and New South Wales to examine the efficacy and safety of a modular multi-modal physical exercise program in 90 prostate cancer survivors with bone metastases. Participants will be randomized to (1) modular multi-modal exercise intervention group or (2) usual medical care group. The modular multi-modal exercise group will receive a 3-month supervised exercise program based on bone lesion location/extent. Measurements for primary and secondary endpoints will take place at baseline, 3 months (end of the intervention) and 6 months follow-up.DiscussionDelaying or preventing skeletal complication and improving physical function for men with bone metastases would provide clinically meaningful benefits to patients. However, exercise programs must be designed and executed with careful consideration of the skeletal complications associated with bone metastatic disease and cumulative toxicities from androgen deprivation such as osteoporosis and increased risk of fractures. The results from this study will form the basis for the development of a specific exercise prescription in this patient group in order to alleviate disease burden, counteract the adverse treatment related side-effects and enhance quality of life.Trial RegistrationACTRN: ACTRN12611001158954

【 授权许可】

CC BY   
© Galvão et al; licensee BioMed Central Ltd. 2011