Pain
Conditions
Keywords
cancer pain, radiation therapy, surgery, incobotulinum toxin
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.
Interventions
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.
Sponsors
Merz North America, Inc.
Yale University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 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. | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | IncobotulinumtoxinA |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
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.
Time frame: 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IncobotulinumtoxinA | Number of Participants With a Significant Reduction in Pain | 8 participants |
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.
Time frame: 12 weeks
Population: Advanced cancer patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IncobotulinumtoxinA | Patients Who Show Improvement in American Pain Association Questionnaire | 3 participants |
Other Pre-specified
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).
Time frame: 12 weeks
Population: Advanced cancer patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IncobotulinumtoxinA | Patients Improved in Patient Global Impression of Change (PGIC) Scale | 7 participants |