Clinical trial NCT01931865: IncobotulinumtoxinA for Treatment of Focal Cancer Pain After Surgery and/or Radiation
Official title: IncobotulinumtoxinA for Treatment of Focal Cancer Pain After Surgery and/or Radiation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pain
Keywords: cancer pain, radiation therapy, surgery, incobotulinum toxin
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Merz North America, Inc.
First posted: 2013-08-29
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: Please contact the PI for more detailed information.

Eligibility 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

Primary outcomes:
measure: Number of Participants With a Significant Reduction in Pain
timeFrame: 12 weeks
Secondary outcomes:
measure: Patients Who Show Improvement in American Pain Association Questionnaire
timeFrame: 12 weeks
Other outcomes:
measure: Patients Improved in Patient Global Impression of Change (PGIC) Scale
timeFrame: 12 weeks
Locations:
city: New Haven
country: United States
facility: Yale Physician Building
state: Connecticut
Study officials:
affiliation: Yale University
name: Bahman Jabbari, MD
role: PRINCIPAL_INVESTIGATOR
References: