IncobotulinumtoxinA for Treatment of Focal Cancer Pain After Surgery and/or Radiation

• Status: Terminated
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborators: Merz North America, Inc.; Merz Pharmaceuticals, LLC
• Treatments: abobotulinumtoxinA; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

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