SFEBES2021 Oral Poster Presentations Endocrine Cancer and Late Effects (4 abstracts)
The evaluation of a musculoskeletal health package intervention to prevent bone toxicity in women with gynaecological malignancies undergoing pelvic radiotherapy. The RadBone randomised controlled feasibility study
Victoria Chatzimavridou Grigoriadou 1 , Lisa Barraclough 2 , Ivona Baricevic-Jones 3 , Robert Bristow 4 , Martin Eden 5 , Kate Haslett 2 , Karen Johnson 2 , Rohit Kochhar 6 , Zoe Merchant 7 , John Moore 8 , Sarah O’Connell 6 , Sally Taylor 9 , Thomas Westwood 6 , Anthony Whetton 3 , Janelle Yorke 9 & Claire E Higham 1
1Department of Endocrinology, Christie Hospital NHS Foundation Trust; University of Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom; 2Department of Clinical Oncology, Christie Hospital NHS Foundation Trust, Manchester, United Kingdom; 3Stoller Biomarker Discovery Centre, Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom; 4Division of Cancer Sciences, The University of Manchester, Manchester, UK; CRUK Manchester Institute and Manchester Cancer Research Centre, Manchester, United Kingdom; 5Manchester Centre for Health Economics, The University of Manchester, Manchester, United Kingdom; 6Department of Radiology, The Christie National Health Service Foundation Trust, Manchester, United Kingdom; 7Programme Lead for the Greater Manchester ‘Prehab4Cancer and Recovery programme’/Highly Specialist Occupational Therapist. GM Cancer alliance hosted by the Christie NHS Foundation Trust, Manchester, United Kingdom; 8Consultant in Anaesthetics and Intensive Care Medicine, Manchester University NHS Foundation Trust. GM Cancer Clinical Director for Prehabilitation and Recovery. University of Manchester and Manchester Metropolitan University, Manchester, United Kingdom; 9The Christie Patient Centred Research Team, The Christie School of Oncology, The Christie NHS Foundation Trust, Wilmslow Road, Manchester, United Kingdom
Background: Bone toxicity and more specifically Radiotherapy Related Insufficiency Fractures (RRIFs) are common late effects of pelvic radiotherapy, associated with increased morbidity and reduced quality of life, while their cost to the health system is currently unknown. The mechanisms underlying RRIFs are not well understood. Effective preventive techniques and management pathways need to be developed and validated with robust clinical and health economic analyses. The RadBone prospective randomized controlled trial (Clinical trial registration: NCT04555317) aims to determine the feasibility and acceptability of a musculoskeletal health package (MHP) intervention in women with gynaecological malignancies receiving pelvic radiotherapy and to preliminary explore the clinical effectiveness of the intervention.
Methods and Analysis: Eighty patients will be randomised to the MHP or standard of care/observational arm. The MHP consists of a three-month prehabilitation personalised exercise package (Prehab4cancer), DXA assessment of bone mineral density, fracture risk estimation using FRAX score and treatment according to the National Osteoporosis Guideline Group (NOGG) recommendations (patients will be divided into 3 risk groups: Low Risk will receive written advice about bone health; Intermediate Risk will receive the written information and Calcium/Vitamin D replacement; High risk will receive bisphosphonate treatment in addition to the above). Participants will be followed using Patient Reported Outcome Measures (PROMs), pelvic MRI scans and fasting blood tests at 6, 12 and 18 months. Baseline (pre-radiotherapy) samples will be taken for MS-SWATH proteomics and weekly during radiotherapy for longitudinal bone turnover markers. The primary outcome is feasibility; including eligibility, screening and recruitment rate, intervention fidelity and attrition rates; acceptability; and health economic variables. Clinical effectiveness and bone turnover markers will be assessed as secondary outcomes. The results of this trial will inform power calculations and the feasibility of an economic evaluation alongside a future multi-centre UK randomised controlled trial.
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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