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

Primary Purpose

Pain

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

IncobotulinumtoxinA

About this trial

This is an interventional treatment trial for Pain focused on measuring cancer pain, radiation therapy, surgery, incobotulinum toxin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Yale Physician Building

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IncobotulinumtoxinA

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01931865

First Posted

August 26, 2013

Last Updated

December 30, 2015

Sponsor

Yale University

Collaborators

Merz North America, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01931865

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Terminated

Why Stopped

lost the recruiting source- no recruitment for the past 18months, PI moving

Study Start Date

September 2012 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

Collaborators

Merz North America, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain

Keywords

cancer pain, radiation therapy, surgery, incobotulinum toxin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IncobotulinumtoxinA

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

IncobotulinumtoxinA

Other Intervention Name(s)

Xeomin

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of Participants With a Significant Reduction in Pain

Description

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Patients Who Show Improvement in American Pain Association Questionnaire

Description

This quality of life scale consists of 10 questions regarding how pain affects your quality of life.

Time Frame

12 weeks

Other Pre-specified Outcome Measures:

Title

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

Description

The Patient Global Impression of Change questionaire asks patient level of satisfaction with current treatment (from very unsatisfactory to very satisfactory).

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bahman Jabbari, MD

Organizational Affiliation

Yale School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yale Physician Building

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06510

Country

United States

12. IPD Sharing Statement

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

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