Chronic PainPhase 1/2NCT04585620
Botulinum Toxin A as Treatment for Chronic Postsurgical Pain Following Lung Cancer Surgery
A Phase 1/2 study testing Onabotulinum Toxin A and Normal saline in people with Chronic Pain and Post-thoracotomy Pain Syndrome, run by Allan Vestergaard Danielsen, MD at 1 site in Denmark.
Trial summary
Chronic postsurgical pain following lung cancer surgery is common with and 20-60 % develop chronic pain which persists more than six months after surgery. Causes and health impact of this pain have been comprehensively studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Post-thoracotomy Pain Syndrome, Pain, Neuropathic
- What is being tested?
- Onabotulinum Toxin A and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2022to 31 Jan 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- Patients of 18 years of age or above.
- Patients who have undergone pulmonary surgery because of suspicion or confirmed pulmonary malignancies.
- Patients who are radically treated for pulmonary malignancy
- Patients who suffers from chronic pain or unpleasant sensation at the site of scar at least six months after surgery with fully healed surgical wounds.
Who cannot join
- Patients who cannot understand oral and written information.
- Patients who were not radically operated.
- Patients with other concomitant or other active cancer diseases.
- Patients with chronic pain in the chest wall prior to surgery.
- Pregnant women or women planning to get pregnant in the study period.
- Patients with autoimmune neuromuscular diseases, sclerosis, peripheral neuromuscular disturbances and general muscle weakness or atrophy.
- Patients with intolerance or allergy to BOTOX®.
- Patients who are at present treated with BTX-A or similar neuromuscular blocking drug or have received such in the past year.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dept. of Cardiothoracic Surgery, Aalborg University Hospital
Aalborg, 9000
Allan V Danielsen, MD, +45 2972 0229, a.danielsen@rn.dk
Jan J Andreasen, MD PhD, +45 9766 6451, jja@rn.dk
About this study
Official title: Botulinum Toxin A as Treatment for Chronic Postsurgical Pain Following Lung Cancer Surgery: a Randomized Controlled Pilot Trial
Chronic postsurgical pain following lung cancer surgery is common with and 20-60 % develop chronic pain which persists more than six months after surgery. Causes and health impact of this pain have been comprehensively studied. Current treatment consists of combination of pain medication, physiotherapy and psychological therapy.
Botulinum Toxin A (BTX-A) has shown promising effects in a variety of chronic postsurgical pain syndromes. The use of BTX-A in lung cancer patients has only been presented in few case reports. No randomized controlled trials (RCT) have been executed to date.
Read more
Study objectives:
Determine recruitment potential among cured lung cancer patients with chronic postsurgical pain for an RCT and if the method of BTX-A administration is feasible and acceptable. Further more, this study will contribute to the stage testing of the hypothesis that chronic pain following thoracic surgery can be treated with BTX-A.
Methods:
Recruitment of test subjects:
Participiants are recruited among former lung cancer patients with chronic postsurgical pain, who have undergone radical treatment for lung cancer at the Department of Cardiothoracic Surgery, Aalborg University Hospital. Potential test subjects are invited by mail / e-mail.
Randomization and blinding:
Participants are randomized to receive a single series of subcutaneous injections with either Onabotulinum Toxin A (active agent) or inactive normal saline (Placebo) at the former operation site. Neither participant nor investigator will know which treatment is given until the end of the trial.
Data collection:
Data is collected by questionnaires delivered and answered by mail or digitally.
Data on the possible effects and possible adverse reactions are collected at multiple times until three months after treatment.
Read the detailed description
Chronic postsurgical pain (CPP) following lung cancer surgery is common with an observed prevalence of 20-60 %. Causes and health impact have been comprehensively studied. Current treatment consists of combination of pain medication, physiotherapy and psychological therapy.
Botulinum Toxin A (BTX-A) has shown promising effects in a variety of chronic postsurgical pain syndromes. The use of BTX-A in lung cancer patients has only been presented in few case reports. No randomized clinical controlled trials (RCT) has been executed to date.
Study objectives:
Primary:
Determine recruitment potential among cured lung cancer patients with CPP for an RCT and if the method of BTX-A administration is feasible and acceptable to the test subjects.
Secondary:
Early stage testing of the hypothesis that CPP following thoracic surgery can be treated with this novel method.
Methods:
Recruitment of test subjects:
Test subjects are recruited among former lung cancer patients with chronic postsurgical pain, who have undergone radical treatment for lung cancer at the Department of Cardiothoracic Surgery, Aalborg University Hospital. Potential test subjects are invited by mail / e-mail.
Randomization and blinding:
Test subjects are randomized to receive a series of injections with either Onabotulinum Toxin A (active agent) or inactive normal saline (Placebo). Neither test subject nor investigator will know which treatment is given until the end of the trial.
Experimental treatment:
The investigator examines the skin area of the test subject at the operation site and performs a sensory examination with pin prick and sensory brush. The area is located and marked and divided into quadrants of one square centimeter. An area of maximum 40 square centimeters is marked.
At a single treatment session, test subjects receives either active agent or placebo through a series of subcutaneous injections. One injection is given in each marked quadrant of the treatment area. The maximal number of injections is 40.
Follow-up:
After the treatment, test subjects report pain symptoms and intensity, use of pain medication and occurrence of adverse events weekly.
After 30 and 90 days after treatment more comprehensive and additional data is collected concerning neuropathic symptoms, activities of daily life, general health and level of function.
Data collection Data is collected by questionnaires delivered to test subjects by mail or digitally.
Endpoints:
Primary:
- Recruitment of 30 test subjects.
- Half of the first half of included test subject must complete the treatment.
- Half of test subjects in total mus complete the treatment.
Secondary:
- Pain at rest, coughing and when active Numerical rating score (NRS) for presence of pain before and after treatment and course of pain symptoms.
- General Health Short form 36 Health Survey on physical, social and mental level of function on a score from 0 to 100.
- Neuropathic Pain Symptoms Inventory (NPSI) NRS
- Activities of daily life Impact and intensity of pain categorically in 16 situations of daily life.
- Patient's Global Impression of Change (PGIC) Rating of global change perceived by the test subject from "More Worse" to "Much better" and a scale from 0 to 10.
- Being tested
- Onabotulinum Toxin A, Normal saline
- Keywords
- Botulinum toxin, Onabotulinum toxin A
- Medical subject headings
- Chronic Pain, Neuralgia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Onabotulinum Toxin ADrug
Also called BTX-A
Series of subcutaneous injections
Normal salineDrug
Also called Placebo
Series of subcutaneous injections
| Study group | Role | What they receive |
|---|---|---|
| BTX-A | Active comparator | Onabotulinum toxin A is reconstructed with 4 ml of normal saline in a vial containing 100 U (Allergen Units).
At a single treatment session, test subjects receive a series of subcutaneous injections with 2,5 U Onabotulinum toxin A equivalent to 0,1 ml of solution after reconstruction. One injection is given per 1 square centimeter in the painful area in relation to the scar on the chest wall. The maximum number of subcutaneous injections is 40, equivalent to a maximum dose of 100 U of Onabotulinum toxin in a total volume of 4 ml solution. The subcutaneous injections are administered using 26G 0.45 x 15 mm cannulae and 1 ml syringes. Receives: Drug: Onabotulinum Toxin A |
| Placebo | Placebo comparator | At a single treatment session, test subjects receive a series of subcutaneous injections with one injection per 1 square centimeter in the painful area in relation to the scar on the chest wall with an inert solution, i.e. 0.1 ml injections of normal saline up to a total volume of 4 ml, depending on the area of the painful area. The subcutaneous injections are administered using 26G 0.45 x 15 mm cannulae and 1 ml syringes. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of recruitment
Recruitment of 30 test subjects within twelve months.
Measured: 12 months
Incidence of treatment procedure disruption
Proportion of test subjects terminating the treatment procedure after randomization by request due to unacceptable pain or discomfort during the procedure.
Measured: 12 months
Secondary outcomes (6)
Neuropathic Pain Symptoms Inventory (NPSI)
Numeric Rating Scale, range 0 (no pain) to 10 (worst pain imaginable) in whole numbers
Measured: Baseline, 1 and 3 moths after treatment
Activities of daily life
Impact and intensity of pain categorically in 16 situations of daily life. Categorically reported as "Avoid", "Major restriction", "Some restriction", "Minor restriction", "No restriction" or "Do not perform"
Measured: Baseline, 1 and 3 months
Patient's Global Impression of Change (PGIC)
Rating of global change perceived by the test subject from "More Worse" to "Much better" and a scale from 0 to 10.
Measured: 1 and 3 months after treatment.
Pain at rest, coughing and when active
Numeric Rating Scale, range 0 (no pain) to 10 (worst pain imaginable) in whole numbers
Measured: Weekly after treatment for three months
General Health
Short form 36 Health Survey on physical, social and mental level of function on a score from 0 to 100.
Measured: Baseline, 1 and 3 months after treatment
Pain at procedure
Evaluation of pain/discomfort at administration of BTX-A using subcutaneous injection in the skin of the chest wall. Numeric Rating Scale, range 0 (no pain) to 10 (worst pain imaginable) in whole numbers
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start1 Sep 2022 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allan Vestergaard Danielsen, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Allan Vestergaard Danielsen, MD, Aalborg University Hospital
- Investigators
- Allan V Danielsen, MD, Principal investigator, Dept. of Cardiothoracic Surgery, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04585620
- Sponsor's protocol ID
- 74719
- Status last verified
- Nov 2021
- First submitted
- 24 Aug 2020
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Botulinum Toxin A as Treatment for Chronic Postsurgical Pain Following Lung Cancer Surgery: a Randomized Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT04585620
- Acronym / sponsor ID
- 74719
- Keywords
- Botulinum toxin, Onabotulinum toxin A
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Allan Vestergaard Danielsen, MDUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic postsurgical pain following lung cancer surgery is common with and 20-60 % develop chronic pain which persists more than six months after surgery. Causes and health impact of this pain have been comprehensively studied. Current treatment consists of combination of pain medication, physiotherapy and psychological therapy.
Botulinum Toxin A (BTX-A) has shown promising effects in a variety of chronic postsurgical pain syndromes. The use of BTX-A in lung cancer patients has only been presented in few case reports. No randomized controlled trials (RCT) have been executed to date.
Study objectives:
Determine recruitment potential among cured lung cancer patients with chronic postsurgical pain for an RCT and if the method of BTX-A administration is feasible and acceptable. Further more, this study will contribute to the stage testing of the hypothesis that chronic pain following thoracic surgery can be treated with BTX-A.
Methods:
Recruitment of test subjects:
Participiants are recruited among former lung cancer patients with chronic postsurgical pain, who have undergone radical treatment for lung cancer at the Department of Cardiothoracic Surgery, Aalborg University Hospital. Potential test subjects are invited by mail / e-mail.
Randomization and blinding:
Participants are randomized to receive a single series of subcutaneous injections with either Onabotulinum Toxin A (active agent) or inactive normal saline (Placebo) at the former operation site. Neither participant nor investigator will know which treatment is given until the end of the trial.
Data collection:
Data is collected by questionnaires delivered and answered by mail or digitally.
Data on the possible effects and possible adverse reactions are collected at multiple times until three months after treatment.
Detailed description
Chronic postsurgical pain (CPP) following lung cancer surgery is common with an observed prevalence of 20-60 %. Causes and health impact have been comprehensively studied. Current treatment consists of combination of pain medication, physiotherapy and psychological therapy.
Botulinum Toxin A (BTX-A) has shown promising effects in a variety of chronic postsurgical pain syndromes. The use of BTX-A in lung cancer patients has only been presented in few case reports. No randomized clinical controlled trials (RCT) has been executed to date.
Study objectives:
Primary:
Determine recruitment potential among cured lung cancer patients with CPP for an RCT and if the method of BTX-A administration is feasible and acceptable to the test subjects.
Secondary:
Early stage testing of the hypothesis that CPP following thoracic surgery can be treated with this novel method.
Methods:
Recruitment of test subjects:
Test subjects are recruited among former lung cancer patients with chronic postsurgical pain, who have undergone radical treatment for lung cancer at the Department of Cardiothoracic Surgery, Aalborg University Hospital. Potential test subjects are invited by mail / e-mail.
Randomization and blinding:
Test subjects are randomized to receive a series of injections with either Onabotulinum Toxin A (active agent) or inactive normal saline (Placebo). Neither test subject nor investigator will know which treatment is given until the end of the trial.
Experimental treatment:
The investigator examines the skin area of the test subject at the operation site and performs a sensory examination with pin prick and sensory brush. The area is located and marked and divided into quadrants of one square centimeter. An area of maximum 40 square centimeters is marked.
At a single treatment session, test subjects receives either active agent or placebo through a series of subcutaneous injections. One injection is given in each marked quadrant of the treatment area. The maximal number of injections is 40.
Follow-up:
After the treatment, test subjects report pain symptoms and intensity, use of pain medication and occurrence of adverse events weekly.
After 30 and 90 days after treatment more comprehensive and additional data is collected concerning neuropathic symptoms, activities of daily life, general health and level of function.
Data collection Data is collected by questionnaires delivered to test subjects by mail or digitally.
Endpoints:
Primary:
- Recruitment of 30 test subjects.
- Half of the first half of included test subject must complete the treatment.
- Half of test subjects in total mus complete the treatment.
Secondary:
- Pain at rest, coughing and when active Numerical rating score (NRS) for presence of pain before and after treatment and course of pain symptoms.
- General Health Short form 36 Health Survey on physical, social and mental level of function on a score from 0 to 100.
- Neuropathic Pain Symptoms Inventory (NPSI) NRS
- Activities of daily life Impact and intensity of pain categorically in 16 situations of daily life.
- Patient's Global Impression of Change (PGIC) Rating of global change perceived by the test subject from "More Worse" to "Much better" and a scale from 0 to 10.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BTX-A | Active comparator | Drug: Onabotulinum Toxin AOnabotulinum toxin A is reconstructed with 4 ml of normal saline in a vial containing 100 U (Allergen Units). At a single treatment session, test subjects receive a series of subcutaneous injections with 2,5 U Onabotulinum toxin A equivalent to 0,1 ml of solution after reconstruction. One injection is given per 1 square centimeter in the painful area in relation to the scar on the chest wall. The maximum number of subcutaneous injections is 40, equivalent to a maximum dose of 100 U of Onabotulinum toxin in a total volume of 4 ml solution. The subcutaneous injections are administered using 26G 0.45 x 15 mm cannulae and 1 ml syringes. |
| Placebo | Placebo comparator | Drug: Normal salineAt a single treatment session, test subjects receive a series of subcutaneous injections with one injection per 1 square centimeter in the painful area in relation to the scar on the chest wall with an inert solution, i.e. 0.1 ml injections of normal saline up to a total volume of 4 ml, depending on the area of the painful area. The subcutaneous injections are administered using 26G 0.45 x 15 mm cannulae and 1 ml syringes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients of 18 years of age or above.
- Patients who have undergone pulmonary surgery because of suspicion or confirmed pulmonary malignancies.
- Patients who are radically treated for pulmonary malignancy
- Patients who suffers from chronic pain or unpleasant sensation at the site of scar at least six months after surgery with fully healed surgical wounds.
Key exclusion criteria (8 listed)
- Patients who cannot understand oral and written information.
- Patients who were not radically operated.
- Patients with other concomitant or other active cancer diseases.
- Patients with chronic pain in the chest wall prior to surgery.
- Pregnant women or women planning to get pregnant in the study period.
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 |
|---|---|---|
| Onabotulinum Toxin AAlso: BTX-ASeries of subcutaneous injections | Drug | BTX-A |
| Normal salineAlso: PlaceboSeries of subcutaneous injections | Drug | Placebo |
Primary outcome
Rate of recruitment
Time frame: 12 months
Recruitment of 30 test subjects within twelve months.
Incidence of treatment procedure disruption
Time frame: 12 months
Proportion of test subjects terminating the treatment procedure after randomization by request due to unacceptable pain or discomfort during the procedure.
6 secondary outcomes
Neuropathic Pain Symptoms Inventory (NPSI)
Time frame: Baseline, 1 and 3 moths after treatment
Activities of daily life
Time frame: Baseline, 1 and 3 months
Patient's Global Impression of Change (PGIC)
Time frame: 1 and 3 months after treatment.
Pain at rest, coughing and when active
Time frame: Weekly after treatment for three months
General Health
Time frame: Baseline, 1 and 3 months after treatment
Pain at procedure
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
- Individual participant dataSharing planned: No
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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.
Allan V Danielsen, MD principal investigator
Dept. of Cardiothoracic Surgery, Aalborg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Onabotulinum Toxin A and Normal saline in people with Chronic Pain and Post-thoracotomy Pain Syndrome, run by Allan Vestergaard Danielsen, MD at 1 site in Denmark.
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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 9 Nov 2021. 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 Denmark. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Allan V Danielsen, MD (+45 29720229, a.danielsen@rn.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of recruitment (time frame: 12 months). The study lists 2 primary outcomes in all. 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 9 Nov 2021; AzTrials last refreshed its copy on 7 Nov 2026.