RadBone: bone toxicity following pelvic radiotherapy - a prospective randomised controlled feasibility study evaluating a musculoskeletal health package in women with gynaecological cancers undergoing pelvic radiotherapy
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Authors
Chatzimavridou-Grigoriadou, ViktoriaBarraclough, Lisa H
Baricevic-Jones, I.
Bristow, Robert G
Eden, M.
Haslett, Kate
Johnson, Karen
Kochhar, Rohit
Merchant, Zoe
Moore, J.
O'Connell, Sarah
Taylor, Sally
Westwood, Thomas
Whetton, A. D.
Yorke, Janelle
Higham, Claire E
Affiliation
Department of Endocrinology, The Christie Hospital NHS Foundation Trust, Manchester, UKIssue Date
2022
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Introduction: Patients receiving radiotherapy are at risk of developing radiotherapy-related insufficiency fractures, which are associated with increased morbidity and pose a significant burden to patients' quality of life and to the health system. Therefore, effective preventive techniques are urgently required. The RadBone randomised controlled trial (RCT) aims to determine the feasibility and acceptability of a musculoskeletal health package (MHP) intervention in women undergoing pelvic radiotherapy for gynaecological malignancies and to preliminary explore clinical effectiveness of the intervention. Methods and analysis: The RadBone RCT will evaluate the addition to standard care of an MHP consisting of a physical assessment of the musculoskeletal health, a 3-month prehabilitation personalised exercise package, as well as an evaluation of the fracture risk and if required the prescription of appropriate bone treatment including calcium, vitamin D and-for high-risk individuals-bisphosphonates. Forty participants will be randomised in each group (MHP or observation) and will be followed for 18 months. The primary outcome of this RCT will be feasibility, including the eligibility, screening and recruitment rate, intervention fidelity and attrition rates; acceptability and health economics. Clinical effectiveness and bone turnover markers will be evaluated as secondary outcomes. Ethics and dissemination: This study has been approved by the Greater Manchester East Research Ethics Committee (Reference: 20/NW/0410, November 2020). The results will be published in peer-reviewed journals, will be presented in national and international conferences and will be communicated to relevant stakeholders. Moreover, a plain English report will be shared with the study participants, patients' organisations and media.Citation
Chatzimavridou Grigoriadou V, Barraclough LH, Baricevic-Jones I, Bristow RG, Eden M, Haslett K, et al. RadBone: bone toxicity following pelvic radiotherapy – a prospective randomised controlled feasibility study evaluating a musculoskeletal health package in women with gynaecological cancers undergoing pelvic radiotherapy. Vol. 12, BMJ Open. BMJ; 2022. p. e056600.Journal
BMJ OpenDOI
10.1136/bmjopen-2021-056600PubMed ID
35701060Additional Links
https://dx.doi.org/10.1136/bmjopen-2021-056600Type
ArticleLanguage
enae974a485f413a2113503eed53cd6c53
10.1136/bmjopen-2021-056600
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