IncobotulinumtoxinA for Treatment of Focal Cancer Pain After Surgery and/or Radiation
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Number of Participants With a Significant Reduction in Pain
研究概览
简要总结
The purpose of this research study is to investigate the safety and effectiveness of botulinum toxin A (Xeomin) ® injections in patients who suffer from focal pain in areas of radiation and/or surgery as a result of cancer treatment. Our hypothesis is that injection of incobotulinum toxin A into an area of local pain, at or around the area of a post-surgical/post radiation scar, relieves the focal cancer pain.
详细描述
Please contact the PI for more detailed information.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Subjects 18- 80 years, both sexes, all races and ethnic groups.
- •Diagnosis of post- surgical/post - radiation cancer pain.
- •Focal pain duration longer than 3 months
- •Pain of moderate to severe intensity ( mean VAS over the previous week >4 )
- •Subjects who are able to read, speak, and understand English.
排除标准
- •Existing significant acute medical condition (i.e. cardiovascular, endocrine, hematologic, neoplastic, infectious, or autoimmune disorders).
- •Pregnancy or planned pregnancy (determined by urine pregnancy test). Women of childbearing age should use a reliable mode of contraception during the study period (abstinence, etc).
- •Active breast feeding.
- •Enrollment in any clinical trial (currently or within the past 3 months) in which treatments are imposed by a protocol.
- •Any subject for whom botulinum toxin treatment would be contraindicated; known allergy or sensitivity to medication.
- •Subjects who are younger than 18 years of age.
- •Neuromuscular-junction disorders.
- •Axis I diagnosis determined by a neurologist or psychiatrist.
- •Use of anesthetic medications within two weeks or corticosteroid injections within 4 weeks of enrollment.
- •Received botulinum toxin injections in the past 4 months.
- •Patients taking high doses of aminoglycosides or other drugs affecting the function of neuromuscular junction ( anticholinergic, muscle relaxants)
- •Patients who have unstable pain in/at sites other than areas of planned injection
研究组 & 干预措施
IncobotulinumtoxinA
The total dose will depend on the extent of the area involved by pain. The injections will be carried out through a 1cc syringe using a ½ to 1 inch needle intramuscularly or subcutaneously (or both). The ttoal dose will not exceed 100 units.
干预措施: IncobotulinumtoxinA (Drug)
结局指标
主要结局
Number of Participants With a Significant Reduction in Pain
时间窗: 12 weeks
visual analogue scale (VAS), a line which represents the level of pain in 10cms and you will show where your pain is on this line (0 no pain, 10 worst pain). A significant reduction is 2 grades on the scale.
次要结局
- Patients Who Show Improvement in American Pain Association Questionnaire(12 weeks)