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
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 urgen...
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BMJ Publishing Group
2022-06-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/6/e056600.full |
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| author | Janelle Yorke Sarah O’Connell Sally Taylor Karen Johnson Robert G Bristow Martin Eden Kate Haslett John Moore Rohit Kochhar Victoria Chatzimavridou Grigoriadou Lisa H Barraclough Ivona Baricevic-Jones Zoe Merchant Thomas Westwood Anthony David Whetton Claire E Higham |
| author_facet | Janelle Yorke Sarah O’Connell Sally Taylor Karen Johnson Robert G Bristow Martin Eden Kate Haslett John Moore Rohit Kochhar Victoria Chatzimavridou Grigoriadou Lisa H Barraclough Ivona Baricevic-Jones Zoe Merchant Thomas Westwood Anthony David Whetton Claire E Higham |
| author_sort | Janelle Yorke |
| collection | DOAJ |
| description | 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.Trial registration number NCT04555317. |
| format | Article |
| id | doaj-art-5840c0d9ec964b16b09e4e9d6aeb2c9c |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-06-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-5840c0d9ec964b16b09e4e9d6aeb2c9c2025-01-28T04:20:15ZengBMJ Publishing GroupBMJ Open2044-60552022-06-0112610.1136/bmjopen-2021-056600RadBone: bone toxicity following pelvic radiotherapy – a prospective randomised controlled feasibility study evaluating a musculoskeletal health package in women with gynaecological cancers undergoing pelvic radiotherapyJanelle Yorke0Sarah O’Connell1Sally Taylor2Karen Johnson3Robert G Bristow4Martin Eden5Kate Haslett6John Moore7Rohit Kochhar8Victoria Chatzimavridou Grigoriadou9Lisa H Barraclough10Ivona Baricevic-Jones11Zoe Merchant12Thomas Westwood13Anthony David Whetton14Claire E Higham15School of Nursing, The Hong Kong Polytechnic University, Hong Kong, Hong KongInfectious Disease, University Hospital Limerick, Dooradoyle, IrelandChristie Patient Centred Research, The Christie NHS Foundation Trust, Manchester, UKDepartment of Clinical Oncology, The Christie Hospital NHS Foundation Trust, Manchester, UKDivision of Cancer Sciences, The University of Manchester, Manchester, UKManchester Centre for Health Economics, The University of Manchester, Manchester, UK1Radiotherapy Related Research, The Christie NHS Foundation Trust, Manchester, UKBarts Liver Centre, Queen Mary University of London, London, UKDepartment of Radiology, The Christie NHS Foundation Trust, Manchester, UKDepartment of Endocrinology, The Christie Hospital NHS Foundation Trust, Manchester, UKDepartment of Clinical Oncology, The Christie Hospital NHS Foundation Trust, Manchester, UK4University of Manchester, Stoller Biomarker Discovery Centre, Manchester, United KingdomManchester Thoracic Oncology Centre, Manchester University NHS Foundation Trust, Manchester, UKDepartment of Radiology, The Christie NHS Foundation Trust, Manchester, UKStoller Biomarker Discovery Centre, The University of Manchester, Manchester, UKDepartment of Endocrinology, The Christie Hospital NHS Foundation Trust, Manchester, UKIntroduction 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.Trial registration number NCT04555317.https://bmjopen.bmj.com/content/12/6/e056600.full |
| spellingShingle | Janelle Yorke Sarah O’Connell Sally Taylor Karen Johnson Robert G Bristow Martin Eden Kate Haslett John Moore Rohit Kochhar Victoria Chatzimavridou Grigoriadou Lisa H Barraclough Ivona Baricevic-Jones Zoe Merchant Thomas Westwood Anthony David Whetton Claire E Higham 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 BMJ Open |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/12/6/e056600.full |
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