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Chronic Pain Canada

Botulinum Toxin A as Treatment for Chronic Postsurgical Pain Following Lung Cancer Surgery

Unknown statusPhase 1, Phase 2NCT04585620
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Botulinum Toxin A as Treatment for Chronic Postsurgical Pain Following Lung Cancer Surgery: a Randomized Controlled Pilot Trial
Conditions
Interventions
Sponsor
Allan Vestergaard Danielsen, MD
Organization
Aalborg University Hospital
Start date
2022-09-01
Primary completion
2023-12-31
Sex
All
Age range
from 18 Years
Results posted
No results posted in this snapshot
Countries
Denmark
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Patients of 18 years of age or above. 2. Patients who have undergone pulmonary surgery because of suspicion or confirmed pulmonary malignancies. 3. Patients who are radically treated for pulmonary malignancy 4. 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. Exclusion Criteria: 1. Patients who cannot understand oral and written information. 2. Patients who were not radically operated. 3. Patients with other concomitant or other active cancer diseases. 4. Patients with chronic pain in the chest wall prior to surgery. 5. Pregnant women or women planning to get pregnant in the study period. 6. Patients with autoimmune neuromuscular diseases, sclerosis, peripheral neuromuscular disturbances and general muscle weakness or atrophy. 7. Patients with intolerance or allergy to BOTOX®. 8. Patients who are at present treated with BTX-A or similar neuromuscular blocking drug or have received such in the past year.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04585620