ACTRN12616001368426已完成未知
Mechanical modulation of tumour biology in advanced breast cancer patients with osteolytic bone metastases: a randomised, controlled study protocol evaluating safety, feasibility and efficacy of exercise.
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 43
研究概览
简要总结
Data is still being analysed. However, the primary outcome ( to establish the safety and feasibility of exercise for advanced breast cancer patients with osteolytic bone metastases ) was positive. That is, our targeted exercise program was safe, and feasibly delivered, with no skeletal adverse events associated with bone metastatic lesions. All results will be published as analyses of the full data-set are completed through-out 2019.
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
- Female
入选标准
- •* Female, aged greater than or equal to 18 years.
- •* Histologically documented breast cancer.
- •* Stable solitary or multiple metastatic osteolytic lesions in the thoracic or lumbar spine.
- •* Greater than or equal to 3 months since last change of current primary therapies.
- •* Greater than or equal to 3 months since commencement of new primary therapies.
- •* Greater than or equal to 4 weeks since last major surgery and fully recovered
- •* Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 1
- •* Medical clearance by treating physician to participate in exercise
排除标准
- •* Brain metastases or small cell neuroendocrine tumours’
- •* Currently receiving radiotherapy for thoracic or lumbar spinal metastases. Patients are permitted to receive radiotherapy for non-spinal bone metastases only during this intervention.
- •* Currently receiving any other experimental treatments or non-approved therapies.
- •* Regular participation in structured aerobic exercise greater than or equal to 2 days per week.
- •* Regular participation in structured resistance exercise greater than or equal to 2 days per week.
- •* Cardiovascular or neurological disorders that could inhibit exercise participation.
- •* Diminished legal or perceived psychological capacity to given informed consent.
研究者
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