PainPhase 2NCT01931865
IncobotulinumtoxinA for Treatment of Focal Cancer Pain After Surgery and/or Radiation
A Phase 2 study testing IncobotulinumtoxinA in people with Pain, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- IncobotulinumtoxinA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Jul 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale Physician Building
New Haven, Connecticut, 06510
About this study
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.
Read the detailed description
Please contact the PI for more detailed information.
- Conditions
- Pain
- Being tested
- IncobotulinumtoxinA
- Keywords
- cancer pain, radiation therapy, surgery, incobotulinum toxin
- Medical subject headings
- Pain, Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IncobotulinumtoxinADrug
Also called Xeomin
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.
| Study group | Role | What they receive |
|---|---|---|
| IncobotulinumtoxinA | Experimental | 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. Receives: Drug: IncobotulinumtoxinA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (1)
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2013 (estimated)
- Study startSep 2012
- Primary completionJun 2015
- Study completionJul 2015
Why it stopped: lost the recruiting source- no recruitment for the past 18months, PI moving
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Merz North America, Inc.
- Responsible party
- Sponsor
- Investigators
- Bahman Jabbari, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01931865
- Sponsor's protocol ID
- 1205010328
- Status last verified
- Dec 2015
- First submitted
- 26 Aug 2013
- Last updated
- 31 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IncobotulinumtoxinA for Treatment of Focal Cancer Pain After Surgery and/or Radiation
- ClinicalTrials.gov ID
- NCT01931865
- Acronym / sponsor ID
- 1205010328
- Conditions
- Pain
- Keywords
- cancer pain, radiation therapy, surgery, incobotulinum toxin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lost the recruiting source- no recruitment for the past 18months, PI moving
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Merz North America, Inc.
- Study start
- Sep 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 29 Aug 2013 (estimated)
- Results
- Posted 31 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IncobotulinumtoxinA | Experimental | Drug: IncobotulinumtoxinAThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IncobotulinumtoxinAAlso: XeominSubject 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. | Drug | IncobotulinumtoxinA |
Primary outcome
Number of Participants With a Significant Reduction in Pain
Time frame: 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.
1 secondary outcome
Patients Who Show Improvement in American Pain Association Questionnaire
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bahman Jabbari, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IncobotulinumtoxinA in people with Pain, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With a Significant Reduction in Pain (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2015.