ACTRN12620000334909撤回未知
Mechanical suppression of osteolytic bone disease in patients with multiple myeloma using precision exercise medicine: a Phase 1 randomised controlled trial.
适应症
试验速览
- 阶段
- 未知
- 状态
- 撤回
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •[1] Multiple myeloma patients with myeloma bone disease (confirmed with clinical imaging). [2] Required to have not engaged in regular structured exercise in the past three months.
- •[3] have no current non-healing skeletal fracture sites,
- •[4] receive medical clearance to engage in supervised exercise by their haematologist (cancer-specific contraindications), and general practitioner (for other contraindications).
- •[5] Is prepared to be randomised to either arm of the study
- •[6] is not currently receiving an experimental therapy (beyond those in standard of care).
- •Patients with stable and unstable skeletal sites will be included with exercise prescriptions customised based on the location of disease-affected skeletal sites and the stability status of the disease-affected skeletal sites. Skeletal stability will be assessed by study clinicians using previously established clinical tools, including Mirel’s scoring system (long bones) and Taneichi’s scoring system (vertebral column). Owing to potential clinical events surrounding spinal osteolytic activity, the spinal instability neoplastic score (SINS) will also be used as a confirmatory tool to support the Taneichi score. In the event of discordance between the two vertebral scoring tools, the higher score will be chosen to remain risk averse. Within a broader multi-modal exercise program, stable lesion sites will receive a targeted and dose-escalated exercise stimulus through mechanical loading, whereas unstable lesion sites will be avoided as per our previous work with bone metastases as a similar clinical paradigm for comparison.
排除标准
- •[1] Have a cancer diagnosis other than multiple myeloma.
- •[2] Does not have Myeloma Bone Disease (clinically confirmed through imaging).
- •[3] Currently engaging in a regular, structured exercise program pre-enrolment.
- •[4] Is not willing to be randomised.
- •[5] Does not receive medical clearance to participate
- •[6] Is currently enrolled in an experimental drug trial.
研究者
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