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    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, Viktoria
    Barraclough, 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
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    Affiliation
    Department of Endocrinology, The Christie Hospital NHS Foundation Trust, Manchester, UK
    Issue Date
    2022
    
    Metadata
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    Abstract
    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 Open
    URI
    http://hdl.handle.net/10541/625373
    DOI
    10.1136/bmjopen-2021-056600
    PubMed ID
    35701060
    Additional Links
    https://dx.doi.org/10.1136/bmjopen-2021-056600
    Type
    Article
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.1136/bmjopen-2021-056600
    Scopus Count
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