Bone Toxicity Following Pelvic Radiotherapy

NCT04555317 | Unknown DMC

• 1 other identifier: CFTSp180
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gynecologic Cancer; Radiotherapy Side Effect; Fracture

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (20)

• Incidence of Radiotherapy Related Insufficiency Fracture (RRIF)

  assessed at 6, 12 , 18 months post radiotherapy

• Longitudinal change in BMD

  assessed at baseline and 18 months

• Longitudinal change in fracture risk using FRAX (inc BMD by DXA)

  assessed at baseline and 18 months

• Longitudinal change in biochemical markers of bone turnover (BTM)

  change from baseline to week 2

• Longitudinal change in biochemical markers of bone turnover (BTM)

  change from baseline to week 3

Study Arms (2)

Standard of Care

NO INTERVENTION

No intervention. Standard of care cancer pathway followed.

Musculoskeletal Health Package

ACTIVE COMPARATOR

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

Interventions

Musculoskeletal health package COMBINATION_PRODUCT

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))

Musculoskeletal Health Package

Eligibility Criteria

• Age: 18 Years - 85 Years
• Gender Eligibility Details: Gynae-oncology patients with cervical or endometrial cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Christie NHS Foundation Trust: lead

Study Sites (1)

Christie Hospital NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 35701060 DERIVED

MeSH Terms

Conditions

Radiation Injuries; Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomly assigned to either an observational arm or an interventional arm consisting of a musculoskeletal health package

Study Record Dates

• First Submitted: September 2, 2020
• First Posted: September 18, 2020
• Study Start: May 17, 2021
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: November 1, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will become available following analysis and initial publication of study findings. No end date.
• 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.

Locations

GB (1)