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

Yale University

Status and phase: Terminated; Phase 2

Conditions: Pain

Treatments: Drug: IncobotulinumtoxinA

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01931865

1205010328

Details and patient eligibility

About

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.

Full description

Please contact the PI for more detailed information.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

IncobotulinumtoxinA

Experimental group

Description:

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.

Treatment:

Drug: IncobotulinumtoxinA