IncobotulinumtoxinA for Treatment of Focal Cancer Pain After Surgery and/or Radiation
| Status: | Terminated |
|---|---|
| Conditions: | Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | September 2012 |
| End Date: | July 2015 |
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.
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.
Please contact the PI for more detailed information.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
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