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dc.contributor.authorHart, Nicolas H
dc.contributor.authorNewton, Robert U
dc.contributor.authorSpry, Nigel A
dc.contributor.authorTaaffe, Dennis R
dc.contributor.authorChambers, Suzanne
dc.contributor.authorFeeney, Kynan T
dc.contributor.authorJoseph, David J
dc.contributor.authorRedfern, Andrew D
dc.contributor.authorFerguson, Tom
dc.contributor.authorGalvao, Daniel A
dc.date.accessioned2020-10-19T05:39:39Z
dc.date.available2020-10-19T05:39:39Z
dc.date.issued2017
dc.identifier.issn2044-6055en_US
dc.identifier.doi10.1136/bmjopen-2016-014458en_US
dc.identifier.urihttp://hdl.handle.net/10072/398469
dc.description.abstractIntroduction Exercise may positively alter tumour biology through numerous modulatory and regulatory mechanisms in response to a variety of modes and dosages, evidenced in preclinical models to date. Specifically, localised and systemic biochemical alterations produced during and following exercise may suppress tumour formation, growth and distribution by virtue of altered epigenetics and endocrine–paracrine activity. Given the impressive ability of targeted mechanical loading to interfere with metastasis-driven tumour formation in human osteolytic tumour cells, it is of equal interest to determine whether a similar effect is observed in sclerotic tumour cells. The study aims to (1) establish the feasibility and safety of a combined modular multimodal exercise programme with spinal isometric training in advanced prostate cancer patients with sclerotic bone metastases and (2) examine whether targeted and supervised exercise can suppress sclerotic tumour growth and activity in spinal metastases in humans. 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.en_US
dc.description.peerreviewedYesen_US
dc.languageEnglishen_US
dc.language.isoeng
dc.publisherBMJ Publishing Groupen_US
dc.publisher.placeUnited Kingdom
dc.relation.ispartofpagefrom1en_US
dc.relation.ispartofpageto11en_US
dc.relation.ispartofissue5en_US
dc.relation.ispartofjournalBMJ Openen_US
dc.relation.ispartofvolume7en_US
dc.subject.fieldofresearchPublic Health and Health Services not elsewhere classifieden_US
dc.subject.fieldofresearchClinical Sciencesen_US
dc.subject.fieldofresearchPublic Health and Health Servicesen_US
dc.subject.fieldofresearchOther Medical and Health Sciencesen_US
dc.subject.fieldofresearchcode111799en_US
dc.subject.fieldofresearchcode1103en_US
dc.subject.fieldofresearchcode1117en_US
dc.subject.fieldofresearchcode1199en_US
dc.subject.keywordsScience & Technologyen_US
dc.subject.keywordsLife Sciences & Biomedicineen_US
dc.subject.keywordsMedicine, General & Internalen_US
dc.subject.keywordsGeneral & Internal Medicineen_US
dc.subject.keywordsQUALITY-OF-LIFEen_US
dc.titleCan exercise suppress tumour growth in advanced prostate cancer patients with sclerotic bone metastases? A randomised, controlled study protocol examining feasibility, safety and efficacyen_US
dc.typeJournal articleen_US
dc.type.descriptionC1 - Articlesen_US
dcterms.bibliographicCitationHart, NH; Newton, RU; Spry, NA; Taaffe, DR; Chambers, S; Feeney, KT; Joseph, DJ; Redfern, AD; Ferguson, T; Galvao, DA, 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, 2017, 7 (5), pp. 1-11en_US
dcterms.licensehttp://creativecommons.org/licenses/by-nc/4.0/en_US
dc.date.updated2020-10-19T05:16:31Z
dc.description.versionVersion of Record (VoR)en_US
gro.rights.copyright© The Author(s) 2017. This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/en_US
gro.hasfulltextFull Text
gro.griffith.authorChambers, Suzanne K.


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