Challenging the Paradigm in Pain Relief for Advanced Breast and Prostate Cancer Patients With Vertebral Metastasis: Vertebral Augmentation With Cement Plus Radiotherapy Versus Radiotherapy. A Randomized, Prospective, Double Blind Pilot Study
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- pain relief; score on pain questionnaire
研究概览
简要总结
The study aims to evaluate if adding vertebroplasty to radiotherapy, in the treatment of spine metastasis from breast and prostate cancer, is preferable to radiotherapy alone. The investigators hypothesize that, by combining vertebral augmentation with cement and radiotherapy, they could achieve an enhancement in pain relief and level of activities, as well as a decrease in the side effects of multiple medications used for pain control.
详细描述
Included patients presenting with spinal metastasis secondary to breast or prostate cancer are randomized to two groups, intervention and control. Both groups receive standard radiotherapy, which is currently the gold standard of care for such patients. The intervention group will also receive a vertebroplasty [single or multiple level(s)], while the control group will receive a simulated vertebroplasty, where local anesthesia and gentle hand manipulation will be used but the vertebra will not be accessed. The primary outcome is pain relief, though other factors such as quality of life and pain medications will also be evaluated.
There will be an interim analysis after half of the patients have been treated with a follow-up of 3 months. In the analysis, comparisons will be made between the two groups and each patient's individual progress will also be analyzed.
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
- Double
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 35 and 75 years old
- •Biopsy-proven breast cancer (BC) or prostate cancer (PC)
- •Radiographic evidence of spine metastases from the BC or PC in the lumbar and/or mid-low thoracic spine
- •Microfractures or compression fractures up to 40% of the original height of the vertebral body in an MRI [magnetic resonance imaging] (reported by an independent radiologist)
- •Incidental back pain (Verbal Analog Scale > 5/10) felt to be related to those metastases
排除标准
- •Spinal cord compression
- •Massive rupture of the posterior wall of the vertebral body (according to blinded radiological report)
- •Coagulopathy (International Normalized Ratio [INR] > 1.5, platelets < 80,000)
- •Inability to communicate in English, French or Spanish
- •Previous radiotherapy to the spine in the area presently affected
- •Mental cognitive impairment
- •Vertebral metastasis without fracture in the MRI
结局指标
主要结局
pain relief; score on pain questionnaire
时间窗: at baseline, 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after
次要结局
- quality of life; score on 2 quality of life questionnaires(at baseline, 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after)
- pain medication(listed at baseline, 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after)
- side effects(listed at 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after)
- cost of medical care(evaluated at baseline, 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after)
- survival(recorded at 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after)
- new vertebral fractures(recorded at 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after)