A Phase 1/2 interventional study of Onabotulinum Toxin A and Normal saline in Chronic Pain, Post-thoracotomy Pain Syndrome and Pain, Neuropathic, sponsored by Allan Vestergaard Danielsen, MD. Status unknown at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-09.
Sponsored by Allan Vestergaard Danielsen, MD · Phase 1/2, Interventional, and Treatment
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.
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:
Secondary:
1,287 studies on the registry are indexed under Neuralgia; 256 are open to participants now.
This study's planned enrollment of 30 is below the median of 52 across 973 interventional studies indexed under Neuralgia.
Browse Neuralgia studies →This is the only study on the registry with Allan Vestergaard Danielsen, MD as lead sponsor.
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Exclusion Criteria:
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.
Drug: Onabotulinum Toxin A
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.
Drug: Normal saline
Series of subcutaneous injections
Also known as: BTX-A
Series of subcutaneous injections
Also known as: Placebo
Rate of recruitment
Recruitment of 30 test subjects within twelve months.
Time frame: 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.
Time frame: 12 months
Neuropathic Pain Symptoms Inventory (NPSI)
Numeric Rating Scale, range 0 (no pain) to 10 (worst pain imaginable) in whole numbers
Time frame: 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"
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: Baseline
Incidence of treatment procedure disruption for the first half of test subjects
Half of the first half of included test subject must complete the treatment.
Time frame: Through study inclusion period of 12 months
Plan to share: No
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