Gynecologic CancerRadBoneNCT04555317
Bone Toxicity Following Pelvic Radiotherapy
A study testing Musculoskeletal health package in people with Gynecologic Cancer and Radiotherapy Side Effect, run by The Christie NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Gynecologic Cancer, Radiotherapy Side Effect, Fracture
- What is being tested?
- Musculoskeletal health package
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 May 2021to Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age over 18 years
- histologically confirmed uterine or cervix cancer
- patients undergoing potentially curative/adjuvant radiotherapy
- ability to give informed consent to participate
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Christie Hospital NHS Foundation Trust
Manchester, M20 4BX
About this study
Official title: 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.
- Conditions
- Gynecologic Cancer, Radiotherapy Side Effect, Fracture
- Being tested
- Musculoskeletal health package
- Medical subject headings
- Radiation Injuries, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Musculoskeletal health packageCombination 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))
| Study group | Role | What they receive |
|---|---|---|
| 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)) Receives: Combination Product: Musculoskeletal health package |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eligibility and screening rate
proportion of patients eligible for the study from the patient population
Measured: baseline
Recruitment and study group allocation rate
number of eligible patients recruited, randomised and allocated to appropriate study populations
Measured: 2 weeks post consent
Recruitment and study group allocation rate
proportion of eligible patients recruited, randomised and allocated to appropriate study populations
Measured: 2 weeks post consent
Intervention fidelity rate
number of patients completing the elements of the study
Measured: end of study 18 months
Intervention fidelity rate
proportion of patients completing the elements of the study
Measured: end of study 18 months
Attrition rate
number of patients lost to follow-up
Measured: end of study 18 months
Patient and physician acceptability y
Patient and physician acceptability assessed with electronic questionnaires
Measured: change from baseline to 6 months
Patient and physician acceptability y
Patient and physician acceptability assessed with electronic questionnaires
Measured: change from baseline to 12 months
Patient and physician acceptability y
Patient and physician acceptability assessed with electronic questionnaires
Measured: change from baseline to 18 months
Health Economic QOL Analysis
EuroQol-5D-5L Quality of Life assessment
Measured: change from baseline to 6 months
Health Economic QOL Analysis
EuroQol-5D-5L Quality of Life assessment
Measured: change from baseline to 12 months
Health Economic QOL Analysis
EuroQol-5D-5L Quality of Life assessment
Measured: change from baseline to 18 months
Secondary outcomes (20)
Incidence of Radiotherapy Related Insufficiency Fracture (RRIF)
Incidence of RRIF assessed by MR
Measured: assessed at 6, 12 , 18 months post radiotherapy
Longitudinal change in BMD
BMD measured by DXA at baseline and 18 months
Measured: assessed at baseline and 18 months
Longitudinal change in fracture risk using FRAX (inc BMD by DXA)
FRAX assessment tool (including femoral neck BMD)
Measured: assessed at baseline and 18 months
Longitudinal change in biochemical markers of bone turnover (BTM)
serum Bone Turnover Markers
Measured: change from baseline to week 2
Longitudinal change in biochemical markers of bone turnover (BTM)
serum Bone Turnover Markers
Measured: change from baseline to week 3
Longitudinal change in biochemical markers of bone turnover (BTM)
serum Bone Turnover Markers
Measured: change from baseline to week 4
Longitudinal change in biochemical markers of bone turnover (BTM)
serum Bone Turnover Markers
Measured: change from baseline to week 5
Longitudinal change in biochemical markers of bone turnover (BTM)
serum Bone Turnover Markers
Measured: change from baseline to week 6
Longitudinal change in biochemical markers of bone turnover (BTM)
serum Bone Turnover Markers
Measured: change from baseline to week 7
Longitudinal change in biochemical markers of bone turnover (BTM)
serum Bone Turnover Markers
Measured: change from baseline to week 8
Longitudinal change in biochemical markers of bone turnover (BTM)
serum Bone Turnover Markers
Measured: change from baseline to week 9
Longitudinal change in biochemical markers of bone turnover (BTM)
serum Bone Turnover Markers
Measured: change from baseline to 6 months
Longitudinal change in biochemical markers of bone turnover (BTM)
serum Bone Turnover Markers
Measured: change from baseline to 12 months
Longitudinal change in biochemical markers of bone turnover (BTM)
serum Bone Turnover Markers
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: change from baseline to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start17 May 2021
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomly assigned to either an observational arm or an interventional arm consisting of a musculoskeletal health package
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Christie NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04555317
- Sponsor's protocol ID
- CFTSp180
- Acronym
- RadBone
- Status last verified
- Aug 2023
- First submitted
- 2 Sep 2020
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 35701060
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Toxicity Following Pelvic Radiotherapy: A Prospective Randomised Controlled Feasibility Study Evaluating a Musculoskeletal Health Package in Women With Gynaecological Cancers Undergoing Pelvic Radiotherapy
- ClinicalTrials.gov ID
- NCT04555317
- Acronym / sponsor ID
- RadBone / CFTSp180
- Conditions
- Gynecologic Cancer, Radiotherapy Side Effect, Fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The Christie NHS Foundation TrustUniversity, hospital or other
- Study start
- 17 May 2021 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 18 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomly assigned to either an observational arm or an interventional arm consisting of a musculoskeletal health package
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –No intervention. Standard of care cancer pathway followed. |
| Musculoskeletal Health Package | Active comparator | Combination Product: Musculoskeletal health package3 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)) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age over 18 years
- histologically confirmed uterine or cervix cancer
- patients undergoing potentially curative/adjuvant radiotherapy
- ability to give informed consent to participate
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Musculoskeletal health package3 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)) | Combination product | Musculoskeletal Health Package |
Primary outcome
Eligibility and screening rate
Time frame: baseline
proportion of patients eligible for the study from the patient population
Recruitment and study group allocation rate
Time frame: 2 weeks post consent
number of eligible patients recruited, randomised and allocated to appropriate study populations
Recruitment and study group allocation rate
Time frame: 2 weeks post consent
proportion of eligible patients recruited, randomised and allocated to appropriate study populations
Intervention fidelity rate
Time frame: end of study 18 months
number of patients completing the elements of the study
Intervention fidelity rate
Time frame: end of study 18 months
proportion of patients completing the elements of the study
Attrition rate
Time frame: end of study 18 months
number of patients lost to follow-up
Patient and physician acceptability y
Time frame: change from baseline to 6 months
Patient and physician acceptability assessed with electronic questionnaires
Patient and physician acceptability y
Time frame: change from baseline to 12 months
Patient and physician acceptability assessed with electronic questionnaires
Patient and physician acceptability y
Time frame: change from baseline to 18 months
Patient and physician acceptability assessed with electronic questionnaires
Health Economic QOL Analysis
Time frame: change from baseline to 6 months
EuroQol-5D-5L Quality of Life assessment
Health Economic QOL Analysis
Time frame: change from baseline to 12 months
EuroQol-5D-5L Quality of Life assessment
Health Economic QOL Analysis
Time frame: change from baseline to 18 months
EuroQol-5D-5L Quality of Life assessment
20 secondary outcomes
Incidence of Radiotherapy Related Insufficiency Fracture (RRIF)
Time frame: assessed at 6, 12 , 18 months post radiotherapy
Longitudinal change in BMD
Time frame: 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
Longitudinal change in biochemical markers of bone turnover (BTM)
Time frame: change from baseline to week 2
Longitudinal change in biochemical markers of bone turnover (BTM)
Time frame: change from baseline to week 3
Longitudinal change in biochemical markers of bone turnover (BTM)
Time frame: change from baseline to week 4
Longitudinal change in biochemical markers of bone turnover (BTM)
Time frame: change from baseline to week 5
Longitudinal change in biochemical markers of bone turnover (BTM)
Time frame: change from baseline to week 6
Longitudinal change in biochemical markers of bone turnover (BTM)
Time frame: change from baseline to week 7
Longitudinal change in biochemical markers of bone turnover (BTM)
Time frame: change from baseline to week 8
Longitudinal change in biochemical markers of bone turnover (BTM)
Time frame: change from baseline to week 9
Longitudinal change in biochemical markers of bone turnover (BTM)
Time frame: change from baseline to 6 months
Longitudinal change in biochemical markers of bone turnover (BTM)
Time frame: change from baseline to 12 months
Longitudinal change in biochemical markers of bone turnover (BTM)
Time frame: change from baseline to 18 months
Quality of Life Assessment : adapted CTCAE pelvic questionnaire
Time frame: change from baseline to 6 months
Quality of Life Assessment : adapted CTCAE pelvic questionnaire
Time frame: change from baseline to 12 months
Quality of Life Assessment : adapted CTCAE pelvic questionnaire
Time frame: change from baseline to 18 months
Quality of Life Assessment: SMFA adapted to lower limbs
Time frame: change from baseline to 6 months
Quality of Life Assessment: SMFA adapted to lower limbs
Time frame: change from baseline to 12 months
Quality of Life Assessment: SMFA adapted to lower limbs
Time frame: change from baseline to 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- Derived from this study: PubMed 35701060Chatzimavridou 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Musculoskeletal health package in people with Gynecologic Cancer and Radiotherapy Side Effect, run by The Christie NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eligibility and screening rate (time frame: baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04555317, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023.