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

NCT01931865 | Terminated Phase 2 Results

• 1 other identifier: 1205010328
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

cancer pain, radiation therapy, surgery, incobotulinum toxin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patients Who Show Improvement in American Pain Association Questionnaire

  12 weeks

Other Outcomes (1)

• Patients Improved in Patient Global Impression of Change (PGIC) Scale

  12 weeks

Study Arms (1)

IncobotulinumtoxinA

EXPERIMENTAL

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

Interventions

IncobotulinumtoxinA DRUG

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.

Also known as: Xeomin

IncobotulinumtoxinA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• Merz North America, Inc.: collaborator

Study Sites (1)

Yale Physician Building

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Pain; Cancer Pain

Interventions

incobotulinumtoxinA

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Open study, small number of patients

Results Point of Contact

• Title: Bahman Jabbari M.D.
• Organization: Yale University School of Medicine

bahman.jabbari@yale.edu

203-737-2464

Study Officials

• Bahman Jabbari, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2013
• First Posted: August 29, 2013
• Study Start: September 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: July 1, 2015
• Last Updated: December 31, 2015
• Results First Posted: December 31, 2015

Record last verified: 2015-12

Locations

US (1)