IncobotulinumtoxinA for Treatment of Focal Cancer Pain After Surgery and/or Radiation
Trial Purpose and Description
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.
- 18 Years - 80 Years
- Subjects 18- 80 years, sexes, all races and ethnic groups.
- Diagnosis of post surgical /post-radiation cancer pain
- Disease duration longer than 3 months
- Pain of moderate to severe intensity ( mean VAS over the previous week >4 )
- Subjects who are eligible to be treated with a botulinum toxin for a therapeutic reason based upon the physicians&rsquo clinical experience.
- Subjects who are able to read, speak, and understand English.
- Existing significant acute medical condition (i.e. cardiovascular, endocrine, hematologic, neoplastic, infectious, or autoimmune disorders).
- Pregnancy or planned pregnancy (determined by urine pregnancy test). The 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.
- Anesthetic medications within two weeks and corticosteroid injections within 4 weeks of enrollment.
- Received botulinum toxin injections in the past 4 months.
- Merz Pharmaceuticals
- Last Updated:
- Study HIC#: