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

• Sponsor: Yale University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01931865
• Collaborator: Merz North America, Inc. (Industry)
• Enrollment: 12
• Location: 1
• Arm: 1
• Duration (Months): 33.9
• Patients Per Site Per Month: 0.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pain	Drug: IncobotulinumtoxinA	Phase 2

Detailed Description

Please contact the PI for more detailed information.

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: IncobotulinumtoxinA for Treatment of Focal Cancer Pain After Surgery and/or Radiation
• Study Start Date: Sep 1, 2012
• Actual Primary Completion Date: Jun 1, 2015
• Actual Study Completion Date: Jul 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Number of Participants With a Significant Reduction in Pain [12 weeks]

   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

1. Patients Who Show Improvement in American Pain Association Questionnaire [12 weeks]

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

Other Outcome Measures

1. Patients Improved in Patient Global Impression of Change (PGIC) Scale [12 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yale Physician Building	New Haven	Connecticut	United States	06510

Sponsors and Collaborators

• Yale University
• Merz North America, Inc.

Investigators

• Principal Investigator: Bahman Jabbari, MD, Yale School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT01931865
• Other Study ID Numbers: 1205010328
• First Posted: Aug 29, 2013
• Last Update Posted: Dec 31, 2015
• Last Verified: Dec 1, 2015

• Keywords provided by Yale University: cancer pain, radiation therapy, surgery, incobotulinum toxin
• Additional relevant MeSH terms: Cancer Pain; incobotulinumtoxinA

Study Results

Participant Flow

Arm/Group Title	IncobotulinumtoxinA
Arm/Group 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 number of injections will not exceed 5 sites. 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.
Period Title: Overall Study
STARTED	12
COMPLETED	8
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	IncobotulinumtoxinA
Arm/Group 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 number of injections will not exceed 5 sites. 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.
Overall Participants	12
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	10 83.3%
>=65 years	2 16.7%
Sex: Female, Male (Count of Participants)
Female	6 50%
Male	6 50%
Region of Enrollment (participants) [Number]
United States	12 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With a Significant Reduction in Pain
Description	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.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	IncobotulinumtoxinA
Arm/Group 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 number of injections will not exceed 5 sites. 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.
Measure Participants	8
Number [participants]	8 66.7%

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Advanced cancer patients

Arm/Group Title	IncobotulinumtoxinA
Arm/Group 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. 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.
Measure Participants	8
Number [participants]	3 25%

3. Other Pre-specified Outcome

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

Outcome Measure Data

Analysis Population Description

Advanced cancer patients

Arm/Group Title	IncobotulinumtoxinA
Arm/Group 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 number of injections will not exceed 5 sites. 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.
Measure Participants	8
Number [participants]	7 58.3%

Adverse Events

Time Frame	3 months- Advised to call the adverse effect immediately
Arm/Group Title	IncobotulinumtoxinA
Arm/Group 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 number of injections will not exceed 5 sites. 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.
All Cause Mortality
	IncobotulinumtoxinA
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	IncobotulinumtoxinA
	Affected / at Risk (%)	# Events
Total	0/12 (0%)
Other (Not Including Serious) Adverse Events
	IncobotulinumtoxinA
	Affected / at Risk (%)	# Events
Total	0/12 (0%)

Limitations/Caveats

Open study, small number of patients

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.