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

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.

Study Overview

• Status: Terminated
• Conditions: Pain
• Intervention / Treatment: Drug: IncobotulinumtoxinA

Detailed Description

Please contact the PI for more detailed information.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale Physician Building

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: IncobotulinumtoxinA; 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.; Other Names: Xeomin

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients Improved in Patient Global Impression of Change (PGIC) Scale	The Patient Global Impression of Change questionaire asks patient level of satisfaction with current treatment (from very unsatisfactory to very satisfactory).	12 weeks

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: Merz North America, Inc.
• Investigators: Principal Investigator: Bahman Jabbari, MD, Yale School of Medicine

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: August 26, 2013
• First Submitted That Met QC Criteria: August 28, 2013
• First Posted (Estimate): August 29, 2013

Study Record Updates

• Last Update Posted (Estimate): December 31, 2015
• Last Update Submitted That Met QC Criteria: December 30, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: cancer pain, radiation therapy, surgery, incobotulinum toxin
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Cancer Pain; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; incobotulinumtoxinA
• Other Study ID Numbers: 1205010328