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

Conditions

Ill-Defined Sites | Pain

Trial Phase

Trial Purpose and Description

Trial Purpose

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.


Participation Guidelines

Age:
18 Years - 80 Years
Gender:
Both

Eligibility Criteria

Inclusion Criteria:

  • 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.

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). 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.
Sponsor:
Merz Pharmaceuticals
Dates:
09/07/2012
Last Updated:
Study HIC#:
1205010328