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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01931865
• Other study ID #: 1205010328
• Status: Terminated
• Phase: Phase 2
• First received: August 26, 2013
• Last updated: December 30, 2015
• Start date: September 2012
• Est. completion date: July 2015

Study information

• Verified date: December 2015
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

Please contact the PI for more detailed information.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: July 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Yale Physician Building	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Merz Pharmaceuticals, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	No
Secondary	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	No