Can exercise suppress tumour growth in advanced prostate cancer patients with sclerotic bone metastases? A randomised, controlled study protocol examining feasibility, safety and efficacy
Journal article
Hart, Nicolas H., Newton, Robert U., Spry, Nigel A., Taaffe, Dennis R., Chambers, Suzanne K., Feeney, Kynan T., Joseph, David J., Redfern, Andrew D., Ferguson, Tom and Galvão, Daniel A.. (2017). Can exercise suppress tumour growth in advanced prostate cancer patients with sclerotic bone metastases? A randomised, controlled study protocol examining feasibility, safety and efficacy. BMJ Open. 7(5), p. Article: e014458. https://doi.org/10.1136/bmjopen-2016-014458
Authors | Hart, Nicolas H., Newton, Robert U., Spry, Nigel A., Taaffe, Dennis R., Chambers, Suzanne K., Feeney, Kynan T., Joseph, David J., Redfern, Andrew D., Ferguson, Tom and Galvão, Daniel A. |
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Abstract | Abstract Methods and analysis A single-blinded, two-armed, randomised, controlled and explorative phase I clinical trial combining spinal isometric training with a modular multimodal exercise programme in 40 men with advanced prostate cancer and stable sclerotic spinal metastases. Participants will be randomly assigned to (1) the exercise intervention or (2) usual medical care. The intervention arm will receive a 3-month, supervised and individually tailored modular multimodal exercise programme with spinal isometric training. Primary endpoints (feasibility and safety) and secondary endpoints (tumour morphology; biomarker activity; anthropometry; musculoskeletal health; adiposity; physical function; quality of life; anxiety; distress; fatigue; insomnia; physical activity levels) will be measured at baseline and following the intervention. Statistical analyses will include descriptive characteristics, t-tests, effect sizes and two-way (group × time) repeated-measures analysis of variance (or analysis of covariance) to examine differences between groups over time. The data-set will be primarily examined using an intention-to-treat approach with multiple imputations, followed by a secondary sensitivity analysis to ensure data robustness using a complete cases approach. Ethics and dissemination Ethics approval was obtained from the Human Research Ethics Committee (HREC) of Edith Cowan University and the Sir Charles Gairdner and Osborne Park Health Care Group. If proven to be feasible and safe, this study will form the basis of future phase II and III trials in human patients with advanced cancer. To reach a maximum number of clinicians, practitioners, patients and scientists, outcomes will be disseminated through national and international clinical, conference and patient presentations, as well as publication in high-impact, peer-reviewed academic journals. Trial registration number ACTRN 12616000179437. |
Year | 2017 |
Journal | BMJ Open |
Journal citation | 7 (5), p. Article: e014458 |
Publisher | BMJ Publishing Group |
ISSN | 2044-6055 |
Digital Object Identifier (DOI) | https://doi.org/10.1136/bmjopen-2016-014458 |
PubMed ID | 28559456 |
Scopus EID | 2-s2.0-85020007304 |
PubMed Central ID | PMC5777463 |
Open access | Published as ‘gold’ (paid) open access |
Research or scholarly | Research |
Page range | 1-11 |
Funder | Australian Research Council (ARC) |
Publisher's version | License File Access Level Open |
Output status | Published |
Publication dates | |
Online | 30 May 2017 |
Publication process dates | |
Accepted | 20 Mar 2017 |
Deposited | 10 Nov 2021 |
ARC Funded Research | This output has been funded, wholly or partially, under the Australian Research Council Act 2001 |
https://acuresearchbank.acu.edu.au/item/8x067/can-exercise-suppress-tumour-growth-in-advanced-prostate-cancer-patients-with-sclerotic-bone-metastases-a-randomised-controlled-study-protocol-examining-feasibility-safety-and-efficacy
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Publisher's version
OA_Hart_2017_Can_exercise_suppress_tumour_growth_in.pdf | |
License: CC BY-NC 4.0 | |
File access level: Open |
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