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

NCT ID: NCT01931865

Last Updated: 2015-12-31

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2015-07-31

Brief Summary

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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

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Conditions

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Pain

Keywords

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cancer pain, radiation therapy, surgery, incobotulinum toxin

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

IncobotulinumtoxinA

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Xeomin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merz North America, Inc.

INDUSTRY

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bahman Jabbari, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Yale Physician Building

New Haven, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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1205010328

Identifier Type: -

Identifier Source: org_study_id