Bone Toxicity Following Pelvic Radiotherapy (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

A randomised controlled clinical feasibility trial to determine the feasibility and acceptability of a "musculoskeletal health package (MHP)" intervention in women undergoing pelvic radiotherapy for gynaecological malignancies and inform power calculations for a definitive trial.

Study Overview

• Status: Active, not recruiting
• Conditions: Gynecologic Cancer; Radiotherapy Side Effect; Fracture
• Intervention / Treatment: Combination product: Musculoskeletal health package

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Claire Higham; Phone Number: 07941170315; Email: claire.higham2@nhs.net
• Study Contact Backup: Name: Louise James; Email: louise.james22@nhs.net

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M20 4BX
    • Christie Hospital NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• age over 18 years
• histologically confirmed uterine or cervix cancer
• patients undergoing potentially curative/adjuvant radiotherapy
• ability to give informed consent to participate

Exclusion Criteria:

• age less than 18 years or greater than 85 years
• patients with pre-existing bone conditions such as: osteoporosis treated with bisphosphonates in the previous 5 years/fibrous dysplasia/osteogenesis imperfecta or other metabolic bone condition
• inability to give informed consent to participate
• home address outside Greater Manchester
• contraindication or intolerance of Magnetic Resonance scanning

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care; No intervention. Standard of care cancer pathway followed.
Active Comparator: Musculoskeletal Health Package; 3 month prehabilitation exercise program during radiotherapy and assessment of BMD at baseline with appropriate management according to fracture risk assessment (with either (a) lifestyle advice, (b) calcium and vitamin D (c) calcium, vitamin D and bisphosphonate (alendronate))	Combination product: Musculoskeletal health package; 3 month prehabilitation exercise program during radiotherapy with assessment of BMD at baseline with appropriate management according to fracture risk assessment (with either (a) lifestyle advice, (b) calcium and vitamin D (c) calcium, vitamin D and bisphosphonate (alendronate))

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eligibility and screening rate	proportion of patients eligible for the study from the patient population	baseline
Recruitment and study group allocation rate	number of eligible patients recruited, randomised and allocated to appropriate study populations	2 weeks post consent
Recruitment and study group allocation rate	proportion of eligible patients recruited, randomised and allocated to appropriate study populations	2 weeks post consent
Intervention fidelity rate	number of patients completing the elements of the study	end of study 18 months
Intervention fidelity rate	proportion of patients completing the elements of the study	end of study 18 months
Attrition rate	number of patients lost to follow-up	end of study 18 months
Patient and physician acceptability y	Patient and physician acceptability assessed with electronic questionnaires	change from baseline to 6 months
Patient and physician acceptability y	Patient and physician acceptability assessed with electronic questionnaires	change from baseline to 12 months
Patient and physician acceptability y	Patient and physician acceptability assessed with electronic questionnaires	change from baseline to 18 months
Health Economic QOL Analysis	EuroQol-5D-5L Quality of Life assessment	change from baseline to 6 months
Health Economic QOL Analysis	EuroQol-5D-5L Quality of Life assessment	change from baseline to 12 months
Health Economic QOL Analysis	EuroQol-5D-5L Quality of Life assessment	change from baseline to 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Radiotherapy Related Insufficiency Fracture (RRIF)	Incidence of RRIF assessed by MR	assessed at 6, 12 , 18 months post radiotherapy
Longitudinal change in BMD	BMD measured by DXA at baseline and 18 months	assessed at baseline and 18 months
Longitudinal change in fracture risk using FRAX (inc BMD by DXA)	FRAX assessment tool (including femoral neck BMD)	assessed at baseline and 18 months
Longitudinal change in biochemical markers of bone turnover (BTM)	serum Bone Turnover Markers	change from baseline to week 2
Longitudinal change in biochemical markers of bone turnover (BTM)	serum Bone Turnover Markers	change from baseline to week 3
Longitudinal change in biochemical markers of bone turnover (BTM)	serum Bone Turnover Markers	change from baseline to week 4
Longitudinal change in biochemical markers of bone turnover (BTM)	serum Bone Turnover Markers	change from baseline to week 5
Longitudinal change in biochemical markers of bone turnover (BTM)	serum Bone Turnover Markers	change from baseline to week 6
Longitudinal change in biochemical markers of bone turnover (BTM)	serum Bone Turnover Markers	change from baseline to week 7
Longitudinal change in biochemical markers of bone turnover (BTM)	serum Bone Turnover Markers	change from baseline to week 8
Longitudinal change in biochemical markers of bone turnover (BTM)	serum Bone Turnover Markers	change from baseline to week 9
Longitudinal change in biochemical markers of bone turnover (BTM)	serum Bone Turnover Markers	change from baseline to 6 months
Longitudinal change in biochemical markers of bone turnover (BTM)	serum Bone Turnover Markers	change from baseline to 12 months
Longitudinal change in biochemical markers of bone turnover (BTM)	serum Bone Turnover Markers	change from baseline to 18 months
Quality of Life Assessment : adapted CTCAE pelvic questionnaire	CTCAE pelvic questionnaire, (common terminology criteria for adverse events). (measures: Bowel questions scored out of 22, urinary questions out of 19 and sexual questions out of 8. Total out of 49: higher score = worse quality of life)	change from baseline to 6 months
Quality of Life Assessment : adapted CTCAE pelvic questionnaire	CTCAE pelvic questionnaire, (common terminology criteria for adverse events). (measures: Bowel questions scored out of 22, urinary questions out of 19 and sexual questions out of 8. Total out of 49: higher score = worse quality of life)	change from baseline to 12 months
Quality of Life Assessment : adapted CTCAE pelvic questionnaire	CTCAE pelvic questionnaire, (common terminology criteria for adverse events). (measures: Bowel questions scored out of 22, urinary questions out of 19 and sexual questions out of 8. Total out of 49: higher score = worse quality of life)	change from baseline to 18 months
Quality of Life Assessment: SMFA adapted to lower limbs	adapted SMFA : short form musculoskeletal function assessment (scores are standardised with high scores indicating poor function. 39 questions min score possible 39, max score possible 195 (raw scores)	change from baseline to 6 months
Quality of Life Assessment: SMFA adapted to lower limbs	adapted SMFA : short form musculoskeletal function assessment (scores are standardised with high scores indicating poor function. 39 questions min score possible 39, max score possible 195 (raw scores)	change from baseline to 12 months
Quality of Life Assessment: SMFA adapted to lower limbs	adapted SMFA : short form musculoskeletal function assessment (scores are standardised with high scores indicating poor function. 39 questions min score possible 39, max score possible 195 (raw scores)	change from baseline to 18 months

Collaborators and Investigators

• Sponsor: The Christie NHS Foundation Trust

Publications and helpful links

General Publications

• Chatzimavridou Grigoriadou V, Barraclough LH, Baricevic-Jones I, Bristow RG, Eden M, Haslett K, Johnson K, Kochhar R, Merchant Z, Moore J, O'Connell S, Taylor S, Westwood T, Whetton AD, Yorke J, Higham CE. 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. 2022 Jun 14;12(6):e056600. doi: 10.1136/bmjopen-2021-056600.

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2021
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: September 2, 2020
• First Submitted That Met QC Criteria: September 14, 2020
• First Posted (Actual): September 18, 2020

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CFTSp180

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data collected during the trial, after deidentification will be available, according to below sponsor requirements: onsent to share data from this study for future research is voluntary. To ensure compliance with regulatory and governance requirements, approval from the sponsor team is required prior to the release of any data generated by this Christie sponsored study, to a third party. Any requests are to be directed towards the-christie.sponsoredresearch@nhs.net for consideration and must follow all local Policies and review procedures. If a proposal is accepted, then the sponsor will work with the requestor to develop any necessary data transfer plans/agreements.
• IPD Sharing Time Frame: Data will become available following analysis and initial publication of study findings. No end date.
• IPD Sharing Access Criteria: Consent to share data from this study for future research is voluntary. To ensure compliance with regulatory and governance requirements, approval from the sponsor team is required prior to the release of any data generated by this Christie sponsored study, to a third party. Any requests are to be directed towards the-christie.sponsoredresearch@nhs.net for consideration and must follow all local Policies and review procedures. If a proposal is accepted, then the sponsor will work with the requestor to develop any necessary data transfer plans/agreements.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No