Authorised Therapeutic exploratory (Phase II) Chronic postsurgical pain (CPSP)

Botulinum toxin A in the Treatment of Chronic Postsurgical Pain in Lung Cancer Patients: A feasibility study

EU CTIS ID: 2026-525669-33-00

What this study is testing

The objective of this trial is to assess the feasibility of conducting a full-scale clinical trial investigating BTX-A for established CPSP following lung cancer surgery. The trial also aim to explore proof of concept for analgesic effect of BTX-A in surgical lung cancer patients. Primary objectives: 1. Establish the rate of recruitment. 2. Establish the percentage of screened patients recruited. 3. Determine study completion percentage.

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Age 18 or older
  • Patients who have undergone curative lung cancer surgery with or without (neo)adjuvant therapy.
  • Patients diagnosed with chronic postsurgical pain following lung cancer surgery, according to current criteria defined by the International Association for the Study of Pain.
  • Report at least moderate pain (defined as ≥4 on a numerical rating scale (NRS) from 0 (no pain) to 10 (worst pain imaginable) AND/OR presence of neuropathic pain assessed by Douleur Neuropathique 4 Questions (DN4), defined as a score of ≥4/10.
  • Able to understand, speak and read Danish.
  • Females of childbearing age/premenopausal must use a safe and approved contraceptive treatment.

You likely can't join if

  • Individuals unable to understand oral and written information.
  • Pregnant females, lactating females, females planning pregnancy, and fertile females not using contraception (hormonal contraceptives or an intrauterine device).
  • Patients who, according to the final histopathological report, were not radically treated for their lung cancer.
  • Patients undergoing examinations or treatments for other concurrent or newly diagnosed cancers.
  • Patients with a pre-existing chronic pain condition in the chest area before surgery.
  • Patients with autoimmune neuromuscular diseases, multiple sclerosis, peripheral neuromuscular disorders, or severe generalized muscle weakness or atrophy.
See the full eligibility criteria
Who can join
  • Age 18 or older
  • Patients who have undergone curative lung cancer surgery with or without (neo)adjuvant therapy.
  • Patients diagnosed with chronic postsurgical pain following lung cancer surgery, according to current criteria defined by the International Association for the Study of Pain.
  • Report at least moderate pain (defined as ≥4 on a numerical rating scale (NRS) from 0 (no pain) to 10 (worst pain imaginable) AND/OR presence of neuropathic pain assessed by Douleur Neuropathique 4 Questions (DN4), defined as a score of ≥4/10.
  • Able to understand, speak and read Danish.
  • Females of childbearing age/premenopausal must use a safe and approved contraceptive treatment.
What rules you out
  • Individuals unable to understand oral and written information.
  • Pregnant females, lactating females, females planning pregnancy, and fertile females not using contraception (hormonal contraceptives or an intrauterine device).
  • Patients who, according to the final histopathological report, were not radically treated for their lung cancer.
  • Patients undergoing examinations or treatments for other concurrent or newly diagnosed cancers.
  • Patients with a pre-existing chronic pain condition in the chest area before surgery.
  • Patients with autoimmune neuromuscular diseases, multiple sclerosis, peripheral neuromuscular disorders, or severe generalized muscle weakness or atrophy.
  • Patients with hypersensitivity or allergy to BTX-A.
  • Patients currently receiving BTX-A treatment or those who have received BTX-A within the past year.
  • Psychiatric comorbidities deemed by the investigators to impact the ability to participate.
  • Active abuse of illicit drugs.

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.