Evidence map›Paper›PMID 35701060›Full record

Trial reportBMJ open2022

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 and 6 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04555317 (Bone Toxicity Following Pelvic Radiotherapy), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.1field-weighted citation impact, top 24% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04555317 naunknown statusnot on this map

Bone Toxicity Following Pelvic Radiotherapy: A Prospective Randomised Controlled Feasibility Study Evaluating a Musculoskeletal Health Package in Women With Gynaecological Cancers Undergoing Pelvic Radiotherapy

TypeinterventionalSponsorThe Christie NHS Foundation TrustRan2021 to 2025Enrolled80ConditionsGynecologic Cancer, Radiotherapy Side Effect, FractureArmsMusculoskeletal health package
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 6 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 5 institutions in 1 country.

Victoria Chatzimavridou GrigoriadouDepartment of Endocrinology, The Christie Hospital NHS Foundation Trust, Manchester, UK.ORCID 0000-0002-9064-0532
Lisa H BarracloughDepartment of Clinical Oncology, The Christie Hospital NHS Foundation Trust, Manchester, UK.
Ivona Baricevic-JonesStoller 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, UK.
Robert G BristowDivision of Cancer Sciences, The University of Manchester, Manchester, UK.
Martin EdenManchester Centre for Health Economics, The University of Manchester, Manchester, UK.
Kate HaslettDepartment of Clinical Oncology, The Christie Hospital NHS Foundation Trust, Manchester, UK.
Karen JohnsonDepartment of Clinical Oncology, The Christie Hospital NHS Foundation Trust, Manchester, UK.
Rohit KochharDepartment of Radiology, The Christie NHS Foundation Trust, Manchester, UK.
Zoe MerchantGreater Manchester 'Prehab4Cancer and Recovery programme'/Highly Specialist Occupational Therapist, GM Cancer alliance hosted by the Christie NHS Foundation Trust, Manchester, UK.
John MooreGM Cancer Clinical Director for Prehabilitation and Recovery, University of Manchester and Manchester Metropolitan University, Manchester, UK.
Sarah O'ConnellDepartment of Radiology, The Christie NHS Foundation Trust, Manchester, UK.
Sally TaylorThe Christie Patient Centred Research Team, The Christie School of Oncology, The Christie NHS Foundation Trust, Manchester, UK.
Thomas WestwoodDepartment of Radiology, The Christie NHS Foundation Trust, Manchester, UK.
Anthony David WhettonStoller Biomarker Discovery Centre, The University of Manchester, Manchester, UK.
Janelle YorkeDepartment of Clinical Oncology, The Christie Hospital NHS Foundation Trust, Manchester, UK.
Claire E HighamDepartment of Endocrinology, The Christie Hospital NHS Foundation Trust, Manchester, UK claire.higham2@nhs.net.
The Christie NHS Foundation Trust · GBManchester Academic Health Science Centre · GBThe Christie Hospital · GBUniversity of Manchester · GBManchester Metropolitan University · GB

Funding

Medical Research Council MR/M008959/1Medical Research Council MR/T024887/1
6 · The paper itself

Abstract

introductionPatients 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.

Indexed as

Genital Neoplasms, FemaleDiphosphonatesFeasibility StudiesFemaleHumansProspective StudiesResearch DesignDiphosphonatesclinical trialsgynaecological oncologymusculoskeletal disordersradiotherapy

Identifiers

PMID35701060
PMCPMC9198686
OpenAlexW4282836766

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.