Bone Toxicity Following Pelvic Radiotherapy (RadBone)

October 31, 2023 updated by: The Christie NHS Foundation Trust

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Eligibility and screening rate
Time Frame: baseline
proportion of patients eligible for the study from the patient population
baseline
Recruitment and study group allocation rate
Time Frame: 2 weeks post consent
number of eligible patients recruited, randomised and allocated to appropriate study populations
2 weeks post consent
Recruitment and study group allocation rate
Time Frame: 2 weeks post consent
proportion of eligible patients recruited, randomised and allocated to appropriate study populations
2 weeks post consent
Intervention fidelity rate
Time Frame: end of study 18 months
number of patients completing the elements of the study
end of study 18 months
Intervention fidelity rate
Time Frame: end of study 18 months
proportion of patients completing the elements of the study
end of study 18 months
Attrition rate
Time Frame: end of study 18 months
number of patients lost to follow-up
end of study 18 months
Patient and physician acceptability y
Time Frame: change from baseline to 6 months
Patient and physician acceptability assessed with electronic questionnaires
change from baseline to 6 months
Patient and physician acceptability y
Time Frame: change from baseline to 12 months
Patient and physician acceptability assessed with electronic questionnaires
change from baseline to 12 months
Patient and physician acceptability y
Time Frame: change from baseline to 18 months
Patient and physician acceptability assessed with electronic questionnaires
change from baseline to 18 months
Health Economic QOL Analysis
Time Frame: change from baseline to 6 months
EuroQol-5D-5L Quality of Life assessment
change from baseline to 6 months
Health Economic QOL Analysis
Time Frame: change from baseline to 12 months
EuroQol-5D-5L Quality of Life assessment
change from baseline to 12 months
Health Economic QOL Analysis
Time Frame: change from baseline to 18 months
EuroQol-5D-5L Quality of Life assessment
change from baseline to 18 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of Radiotherapy Related Insufficiency Fracture (RRIF)
Time Frame: assessed at 6, 12 , 18 months post radiotherapy
Incidence of RRIF assessed by MR
assessed at 6, 12 , 18 months post radiotherapy
Longitudinal change in BMD
Time Frame: assessed at baseline and 18 months
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)
Time Frame: assessed at baseline and 18 months
FRAX assessment tool (including femoral neck BMD)
assessed at baseline and 18 months
Longitudinal change in biochemical markers of bone turnover (BTM)
Time Frame: change from baseline to week 2
serum Bone Turnover Markers
change from baseline to week 2
Longitudinal change in biochemical markers of bone turnover (BTM)
Time Frame: change from baseline to week 3
serum Bone Turnover Markers
change from baseline to week 3
Longitudinal change in biochemical markers of bone turnover (BTM)
Time Frame: change from baseline to week 4
serum Bone Turnover Markers
change from baseline to week 4
Longitudinal change in biochemical markers of bone turnover (BTM)
Time Frame: change from baseline to week 5
serum Bone Turnover Markers
change from baseline to week 5
Longitudinal change in biochemical markers of bone turnover (BTM)
Time Frame: change from baseline to week 6
serum Bone Turnover Markers
change from baseline to week 6
Longitudinal change in biochemical markers of bone turnover (BTM)
Time Frame: change from baseline to week 7
serum Bone Turnover Markers
change from baseline to week 7
Longitudinal change in biochemical markers of bone turnover (BTM)
Time Frame: change from baseline to week 8
serum Bone Turnover Markers
change from baseline to week 8
Longitudinal change in biochemical markers of bone turnover (BTM)
Time Frame: change from baseline to week 9
serum Bone Turnover Markers
change from baseline to week 9
Longitudinal change in biochemical markers of bone turnover (BTM)
Time Frame: change from baseline to 6 months
serum Bone Turnover Markers
change from baseline to 6 months
Longitudinal change in biochemical markers of bone turnover (BTM)
Time Frame: change from baseline to 12 months
serum Bone Turnover Markers
change from baseline to 12 months
Longitudinal change in biochemical markers of bone turnover (BTM)
Time Frame: change from baseline to 18 months
serum Bone Turnover Markers
change from baseline to 18 months
Quality of Life Assessment : adapted CTCAE pelvic questionnaire
Time Frame: change from baseline to 6 months
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
Time Frame: change from baseline to 12 months
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
Time Frame: change from baseline to 18 months
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
Time Frame: change from baseline to 6 months
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
Time Frame: change from baseline to 12 months
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
Time Frame: change from baseline to 18 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Christie NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 17, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 18, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 1, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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