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

Study Overview
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Brief Summary
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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
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Please contact the PI for more detailed information.

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

Conditions
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Pain

Intervention / Treatment
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* Drug: IncobotulinumtoxinA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IncobotulinumtoxinA<br>The total dose will depend on the extent of the area involved by pain. The injections will be carried out through a 1cc syringe using a ½ to 1 inch needle intramuscularly or subcutaneously (or both). The ttoal dose will not exceed 100 units. | Drug: IncobotulinumtoxinA<br>* Subject will receive Xeomin, injected into the area of reported focal pain associated with prior cancer treatment. The total dose will depend on the extent of the area involved by pain. botulinum toxin which is marketed under the trade name of Xeomin. Xeomin is approved by FDA for certain conditions.<br>* Other names: Xeomin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With a Significant Reduction in Pain | visual analogue scale (VAS), a line which represents the level of pain in 10cms and you will show where your pain is on this line (0 no pain, 10 worst pain). A significant reduction is 2 grades on the scale. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients Who Show Improvement in American Pain Association Questionnaire | This quality of life scale consists of 10 questions regarding how pain affects your quality of life. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer pain, radiation therapy, surgery, incobotulinum toxin