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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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)) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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)) |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Gynae-oncology patients with cervical or endometrial cancer
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Christie Hospital NHS Foundation Trust | Manchester | M20 4BX | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35701060 | Derived | 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. |
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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.
Data will become available following analysis and initial publication of study findings. No end date.
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.
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| ID | Term |
|---|---|
| D011832 | Radiation Injuries |
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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Patients will be randomly assigned to either an observational arm or an interventional arm consisting of a musculoskeletal health package
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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 |
| 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 |