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:
Participant gender:
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.