Percutaneous Cordotomy for Pain Palliation in Advanced Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Reduction in pain intensity
研究概览
简要总结
This trial studies how well cordotomy works in reducing pain in patients with cancer that has spread to other places in the body (advanced). Cordotomy is performed on the spinal cord with a needle and guided by computed tomography scans and is designed to help reduce pain. This study is being done to learn if a cordotomy reduces pain in patients with unmanageable cancer pain.
详细描述
PRIMARY OBJECTIVES:
I. Assess the efficacy of cordotomy for patients with unilateral advanced cancer pain.
SECONDARY OBJECTIVES:
I. Define the patient experience of cordotomy for cancer pain refractory to palliative care.
II. Determine whether magnetic resonance imaging (MRI) can be used as a noninvasive biomarker for a successful cordotomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
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
- •Ability to provide informed consent
- •Has undergone 3 palliative care evaluations
- •Pain intensity >= 4 on a 0-10 numerical scale
- •Unilateral pain due to cancer below the shoulder level (arm, trunk, hip, leg)
排除标准
- •Uncorrectable coagulopathy
- •Large intracranial mass
- •Inability to complete assessment forms
- •Life expectancy < 1 month
- •Contraindication to intravenous sedation
- •Morphine allergy
研究组 & 干预措施
Group II (morphine, fake cordotomy)
Patients receive morphine via injection into the spine and undergo a fake cordotomy over 1-2 hours.
干预措施: Questionnaire Administration (Other)
Group I (cordotomy)
Patients undergo a cordotomy over 1-2 hours.
干预措施: Cordotomy (Procedure)
Group I (cordotomy)
Patients undergo a cordotomy over 1-2 hours.
干预措施: Questionnaire Administration (Other)
Group II (morphine, fake cordotomy)
Patients receive morphine via injection into the spine and undergo a fake cordotomy over 1-2 hours.
干预措施: Morphine (Drug)
Group II (morphine, fake cordotomy)
Patients receive morphine via injection into the spine and undergo a fake cordotomy over 1-2 hours.
干预措施: Sham Intervention (Procedure)
结局指标
主要结局
Reduction in pain intensity
时间窗: Up to 6 months
Will be measured by the Edmonton Symptom Assessment Scale (ESAS).
次要结局
- Other ESAS symptoms(Up to 6 months)
- Brief Pain Inventory pain interference items(Up to 6 months)