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

Victoria Chatzimavridou Grigoriadou, Lisa H Barraclough, Ivona Baricevic-Jones, Robert G Bristow, Martin Eden, Kate Haslett, Karen Johnson, Rohit Kochhar, Zoe Merchant, John Moore, Sarah O'Connell, Sally Taylor, Thomas Westwood, Anthony David Whetton, Janelle Yorke, Claire E Higham, Victoria Chatzimavridou Grigoriadou, Lisa H Barraclough, Ivona Baricevic-Jones, Robert G Bristow, Martin Eden, Kate Haslett, Karen Johnson, Rohit Kochhar, Zoe Merchant, John Moore, Sarah O'Connell, Sally Taylor, Thomas Westwood, Anthony David Whetton, Janelle Yorke, Claire E Higham

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.

Trial registration number: NCT04555317.

Keywords: clinical trials; gynaecological oncology; musculoskeletal disorders; radiotherapy.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.

Figures

Figure 1
Figure 1
Recruitment, randomisation process and description of the stratified interventions (#: fracture). BP, blood pressure; DXA, dual-energy X-ray absorptiometry; FRAX, fracture risk assessment.
Figure 2
Figure 2
Study flow chart; assessments and outcome time-points. C+R, consent and randomisation; CV, clinic visit; DXA, dual energy X-ray absorptiometry; EBRT, external beam radiotherapy; eGFR, estimated glomerular filtration rate; HR, high risk; MHP, musculoskeletal health package arm; NHS, National Health System; Ob, observational arm.

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