Study protocol
Efficacy and safety of a modular multi-modal exercise program in prostate cancer patients with bone metastases: a randomized controlled trial
1 Edith Cowan University Health and Wellness Institute and School of Exercise and Health Sciences, Edith Cowan University, Joondalup, Australia
2 School of Environmental and Life Sciences, University of Newcastle, Ourimbah, Australia
3 Department of Radiation Oncology, Sir Charles Gairdner Hospital, Nedlands, Australia
4 Faculty of Medicine, University of Western Australia, Nedlands, Australia
5 Griffith Health Institute, Griffith University, Gold Coast, Australia
6 Viertel Centre for Research in Cancer Control, Cancer Council Queensland, Brisbane, Australia
7 School of Medicine and Public Health, University of Newcastle, Newcastle, Australia
8 Newcastle Mater Hospital, Newcastle, Australia
9 Perth Radiological Clinic, Joondalup Health Campus, Joondalup, Australia
BMC Cancer 2011, 11:517 doi:10.1186/1471-2407-11-517
Published: 13 December 2011Abstract
Background
The 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/Design
Multi-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.
Discussion
Delaying 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 Registration
ACTRN: ACTRN12611001158954
