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

Phase 2

Terminated

• Conditions: Pain
• Interventions: Drug: IncobotulinumtoxinA

• Registration Number: NCT01931865
• Lead Sponsor: Yale University

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.

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2013-08-26
• Study First Submitted QC: 2013-08-28
• Study First Posted: 2013-08-29
• Primary Completion: 2015-06
• Study Completion: 2015-07
• Results First Submitted: 2015-08-31
• Status Verified: 2015-12
• Results First Submitted QC: 2015-12-30
• Last Update Submitted: 2015-12-30
• Results First Posted: 2015-12-31
• Last Update Posted: 2015-12-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IncobotulinumtoxinA	IncobotulinumtoxinA	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With a Significant Reduction in Pain	12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Patients Who Show Improvement in American Pain Association Questionnaire	12 weeks	This quality of life scale consists of 10 questions regarding how pain affects your quality of life.

Trial Locations

Locations (1)

Yale Physician Building; 🇺🇸 New Haven, Connecticut, United States