Prospective Study Determining the Pain Response, Functional Interference and Quality of Life in Patients Undergoing Radiofrequency Ablation Assisted Vertebroplasty/ Cementoplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Pain response
研究概览
简要总结
Bone metastases are a cause of significant morbidity in cancer patients. In patients who die from breast, prostate, and lung cancer, autopsy studies have shown that up to 85% have evidence of bone metastases at the time of death (1). These metastases frequently give rise to complications that reduce patients' quality of life. These include: pain, fractures, and decreased mobility, ultimately reducing performance status.
Radiofrequency ablation therapy with cementoplasty/vertebroplasty for painful bone metastases has been shown to be feasible, efficacious, and safe. However, patient reported outcomes have yet to be determined.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically proven malignancy.
- •Patients aged 18 and above.
- •Advanced cancer with bone metastasis(es) to the spine and/or pelvis
- •Symptomatic with axial pain from spinal lesions and at risk for pathological fracture, or, pathological fracture without spinal cord compromise
- •Karnofsky Performance Status (KPS) greater than or equal to 40 at the time of baseline evaluation.
- •Is planned to receive RFA and/or cementoplasty with treatment to all sites being followed for study.
- •Is able to provide worst pain score at bony metastatic site(s).
- •Patient is able and willing to fill out daily diary.
- •Patients must be able to provide informed consent prior to being enrolled to the study.
排除标准
- •Progressive neurological compromise
- •Pathological fracture of vertebrae with significant cortical involvement or spinal canal compromise
- •Central nervous system metastases
- •Inability to record pain score, complete diary and communicate this to study personnel.
结局指标
主要结局
Pain response
时间窗: Baseline to 6 weeks post treatment
To determine the complete and partial pain response rates in patients who undergo radiofrequency ablation (RFA) and/or cementoplasty/vertebroplasty for spinal/pelvic metastases.
次要结局
- Quality of Life(Baseline - 6 weeks post treatment)
- Functional Interference(Baseline - 6 weeks post treatment)
- Side-effects(Baseline-6 weeks post treatment)
研究者
Dr. Elizabeth David
PI
Sunnybrook Health Sciences Centre