Clinical trial · Interventional
IncobotulinumtoxinA for Treatment of Focal Cancer Pain After Surgery and/or Radiation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): lost the recruiting source- no recruitment for the past 18months, PI moving
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IncobotulinumtoxinA | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IncobotulinumtoxinA
- 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.
- interventionNames
- Drug: IncobotulinumtoxinA
Primary outcomes (1)
- measure
- Number of Participants With a Significant Reduction in Pain
- timeFrame
- 12 weeks
- 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.
Secondary outcomes (1)
- measure
- Patients Who Show Improvement in American Pain Association Questionnaire
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available