IncobotulinumtoxinA for Treatment of Focal Cancer Pain After Surgery and/or Radiation
Stopped early · Phase 2
Conditions studied: Pain
In brief
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.
Key facts
- Study ID
- NCT01931865
- Run by
- Yale University
- People needed
- 12
- Starts
- 2012-09-01
- Expected to finish
- 2015-07-01
- Last updated by the study team
- 2015-12-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Yale Physician Building — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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