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

• Status: Not yet recruiting
• Trial end date: 2024-01-31
• Target enrollment: 0
• Participant gender: All

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. 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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allan Vestergaard Danielsen, MD

Criteria

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.