Bone Toxicity Following Pelvic Radiotherapy
- Conditions
- FractureGynecologic CancerRadiotherapy Side Effect
- Interventions
- Combination Product: Musculoskeletal health package
- Registration Number
- NCT04555317
- Lead Sponsor
- The Christie NHS Foundation Trust
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 80
- age over 18 years
- histologically confirmed uterine or cervix cancer
- patients undergoing potentially curative/adjuvant radiotherapy
- ability to give informed consent to participate
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Musculoskeletal Health Package 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))
- Primary Outcome Measures
Name Time Method Patient and physician acceptability y change from baseline to 18 months Patient and physician acceptability assessed with electronic questionnaires
Recruitment and study group allocation rate 2 weeks post consent proportion of eligible patients recruited, randomised and allocated to appropriate study populations
Attrition rate end of study 18 months number of patients lost to follow-up
Intervention fidelity rate end of study 18 months proportion of patients completing the elements of the study
Eligibility and screening rate baseline proportion of patients eligible for the study from the patient population
Health Economic QOL Analysis change from baseline to 18 months EuroQol-5D-5L Quality of Life assessment
- Secondary Outcome Measures
Name Time Method Longitudinal change in fracture risk using FRAX (inc BMD by DXA) assessed at baseline and 18 months FRAX assessment tool (including femoral neck BMD)
Quality of Life Assessment: SMFA adapted to lower limbs 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)
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
Quality of Life Assessment : adapted CTCAE pelvic questionnaire 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)
Longitudinal change in biochemical markers of bone turnover (BTM) change from baseline to 18 months serum Bone Turnover Markers
Trial Locations
- Locations (1)
Christie Hospital NHS Foundation Trust
🇬🇧Manchester, United Kingdom