Bone Toxicity Following Pelvic Radiotherapy: A Prospective Randomised Controlled Feasibility Study Evaluating a Musculoskeletal Health Package in Women With Gynaecological Cancers Undergoing Pelvic Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Patient and physician acceptability y
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age over 18 years
- •histologically confirmed uterine or cervix cancer
- •patients undergoing potentially curative/adjuvant radiotherapy
- •ability to give informed consent to participate
排除标准
- •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
结局指标
主要结局
Patient and physician acceptability y
时间窗: change from baseline to 18 months
Patient and physician acceptability assessed with electronic questionnaires
Attrition rate
时间窗: end of study 18 months
number of patients lost to follow-up
Eligibility and screening rate
时间窗: baseline
proportion of patients eligible for the study from the patient population
Health Economic QOL Analysis
时间窗: change from baseline to 18 months
EuroQol-5D-5L Quality of Life assessment
Recruitment and study group allocation rate
时间窗: 2 weeks post consent
number of eligible patients recruited, randomised and allocated to appropriate study populations
Intervention fidelity rate
时间窗: end of study 18 months
number of patients completing the elements of the study
次要结局
- Longitudinal change in fracture risk using FRAX (inc BMD by DXA)(assessed at baseline and 18 months)
- Incidence of Radiotherapy Related Insufficiency Fracture (RRIF)(assessed at 6, 12 , 18 months post radiotherapy)
- Longitudinal change in BMD(assessed at baseline and 18 months)
- Quality of Life Assessment: SMFA adapted to lower limbs(change from baseline to 18 months)
- Quality of Life Assessment : adapted CTCAE pelvic questionnaire(change from baseline to 18 months)
- Longitudinal change in biochemical markers of bone turnover (BTM)(change from baseline to 18 months)