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Feasibility Study of Clostridium Botulinum Neurotoxin Type A for Chronic Postsurgical Pain in Lung Cancer Patients

Registered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

A group of people who have undergone surgery for lung cancer sometimes continue to feel pain for months after the operation. This ongoing discomfort is called Chronic postsurgical pain. The study will use a medication known as Botulinum toxin A, supplied as the product Xeomin, which is given by a small injection under the skin of the chest wall.

The purpose of the study is to find out whether it is possible to run a larger trial that tests whether this medication can safely reduce the long‑lasting pain that some patients experience after lung cancer surgery.

Participants who meet the basic criteria will be asked to join, receive the injection, and then complete a series of brief questionnaires about their pain and any side effects at several follow‑up visits. The study will track how many people agree to join, how many complete the treatment and follow‑up, and will collect information on how well the injection method is tolerated.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and consent

    After joining the study you will be asked to read and sign an informed consent form that explains the purpose of the trial and what is expected of you.

    The research team will then perform screening to confirm that you have chronic postsurgical pain after lung cancer surgery and meet all other eligibility criteria.

  2. Step 2

    Baseline assessment

    Once you are confirmed eligible, you will complete a series of questionnaires that record your current pain level, medical history, and any other relevant information.

    These initial measurements serve as a reference point for evaluating any changes during the trial.

  3. Step 3

    Study medication administration

    You will receive a single subcutaneous injection of botulinum toxin a (product name xeomin).

    The injection contains 100 international units (iu) of the medication and is given in the chest wall area.

    The dose is administered only once during the study.

  4. Step 4

    Immediate observation

    After the injection you will be observed for a short period to monitor any immediate side effects or reactions.

    The staff will check how you feel and record any observations.

  5. Step 5

    Follow‑up visits

    You will attend scheduled follow‑up visits for the remainder of the study period.

    At each visit you will complete additional questionnaires and report any side effects or changes in pain.

    The purpose of these visits is to assess the tolerability of the injection and to gather information on pain relief.

  6. Step 6

    Study completion

    The trial concludes when you have completed all required follow‑up assessments and questionnaires.

    Your participation data will be used to evaluate the feasibility of larger studies and the potential pain‑relieving effect of the medication.

Who can join the trial?

7 criteria

  • Be 18 years old or older.
  • Have had lung cancer surgery that was intended to cure the cancer, whether or not you also received extra treatment before or after the operation.
  • Have chronic postsurgical pain that continues for a long time after the lung cancer surgery, as defined by the International Association for the Study of Pain.
  • Feel at least moderate pain, which means you rate your pain 4 or higher on a 0‑to‑10 numerical rating scale (NRS), or you have nerve‑related pain that scores 4 or higher on the DN4 questionnaire (a short survey used to identify nerve pain).
  • Be able to understand, speak, and read Danish.
  • If you are a woman who could become pregnant, you must use a safe and approved form of birth control (contraceptive treatment).
  • Both men and women are allowed to participate.

Who cannot join the trial?

10 criteria

  • Cannot understand the spoken or written information about the study.
  • Pregnant, breastfeeding, planning to become pregnant, or a woman who can become pregnant and is not using reliable birth control such as hormonal methods or an intrauterine device.
  • Had lung cancer surgery that was not completely removed according to the final pathology report (not a radical treatment).
  • Is having examinations or treatments for another cancer at the same time.
  • Had chronic pain in the chest area before the lung surgery.
  • Has autoimmune neuromuscular diseases (where the immune system attacks nerves or muscles), multiple sclerosis, peripheral neuromuscular disorders, or severe overall muscle weakness or wasting.
  • Is allergic or overly sensitive (hypersensitive) to BTX‑A.
  • Is currently receiving BTX‑A treatment or received it within the past year.
  • Has psychiatric problems that the investigators think would make it hard to take part in the study.
  • Is actively abusing illegal drugs.
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Investigated drugs

Xeomin is a medication that contains a purified form of botulinum toxin type A. In this study it is injected under the skin near the area where patients had lung cancer surgery. The purpose of the injection is to see if the toxin can block the nerve signals that cause chronic pain after surgery. Researchers are testing whether this treatment can safely reduce pain and whether a larger trial could be done in the future.

What is already known about the treatment

Xeomin - It comes as a sterile solution for subcutaneous injection, each vial providing 100 international units of botulinum toxin type A that is free of complexing proteins. The product is an approved drug widely used for conditions such as muscle spasticity, cosmetic wrinkle reduction, and some pain disorders, and it is well documented in medical literature. It works by blocking the release of acetylcholine at nerve endings, which reduces muscle activity and also dampens pain‑signal transmission. Pharmacologically, it is classified as a botulinum neurotoxin (ATC code M03AX01).

Investigated diseases

Chronic postsurgical pain (CPSP) - Chronic postsurgical pain is pain that lasts for at least three months after a surgical procedure, beyond the usual healing period. It typically appears in the area of the incision or nearby tissues and may feel like aching, burning, or pressure. The pain can begin soon after surgery and may become steady or fluctuate over time. It may spread to surrounding regions as the nervous system becomes more sensitive. If not addressed, the discomfort can gradually increase during everyday activities.
Trial detailsLast updated 14 Oct 2026
Age18+ yearsPhasePhase IITrial ID2026-525669-33-00Protocol codeBTX-CPSPEstimated enrolment15 patientsSponsorAalborg University Hospital

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