Fracture, Gynecologic Cancer, Radiotherapy Side Effect
Conditions
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.
Interventions
COMBINATION_PRODUCTMusculoskeletal 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))
Sponsors
The Christie NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients will be randomly assigned to either an observational arm or an interventional arm consisting of a musculoskeletal health package
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health Economic QOL Analysis | change from baseline to 6 months | EuroQol-5D-5L Quality of Life assessment |
| Eligibility and screening rate | baseline | proportion of patients eligible for the study from the patient population |
| Recruitment and study group allocation rate | 2 weeks post consent | number of eligible patients recruited, randomised and allocated to appropriate study populations |
| Intervention fidelity rate | end of study 18 months | number of patients completing the elements of the study |
| Attrition rate | end of study 18 months | number of patients lost to follow-up |
| Patient and physician acceptability y | change from baseline to 6 months | Patient and physician acceptability assessed with electronic questionnaires |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Radiotherapy Related Insufficiency Fracture (RRIF) | assessed at 6, 12 , 18 months post radiotherapy | Incidence of RRIF assessed by MR |
| Longitudinal change in BMD | assessed at baseline and 18 months | BMD measured by DXA at baseline and 18 months |
| Longitudinal change in fracture risk using FRAX (inc BMD by DXA) | assessed at baseline and 18 months | FRAX assessment tool (including femoral neck BMD) |
| Longitudinal change in biochemical markers of bone turnover (BTM) | change from baseline to week 2 | serum Bone Turnover Markers |
| Quality of Life Assessment : adapted CTCAE pelvic questionnaire | 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) |
| Quality of Life Assessment: SMFA adapted to lower limbs | 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) |
Countries
United Kingdom
Outcome results
None listed