Prospective, randomized, blinded, comparative study between botulinum toxin and topical capsaicin in the treatment of postmastectomy syndrome. Pilot study
After breast surgery, some women develop long-term nerve pain around the chest, armpit, or scar. This is known as postmastectomy pain syndrome. It can cause burning, stabbing, or tight, numb feelings that are difficult to treat with standard painkillers. This trial compares two targeted treatments to find out which is more helpful. One is an injection of Xeomin, a purified protein that relaxes nerves and muscles. The other is Qutenza, a medicated skin patch containing capsaicin, a natural substance found in chilli peppers that numbs pain receptors in the skin. Participants will receive one of the two treatments. Researchers will track changes in pain levels, side effects, and overall quality of life. The goal is to give doctors and patients clearer information on the best ways to manage this challenging type of post-surgery pain.
At a glance
What is this study about?
Having breast surgery is a major step in cancer care, but for some women, pain can linger long after the surgical wounds have healed. This ongoing discomfort is called postmastectomy pain syndrome. It happens when delicate nerves are stretched or injured during surgery, causing sensations like burning, stabbing, tenderness, or tightness. Because nerve pain behaves differently from ordinary aches, standard painkillers like paracetamol often do not provide enough relief.
This clinical trial is testing two modern treatments to see which offers better relief. The first treatment is Xeomin, an injection of botulinum toxin. While well known for cosmetic uses, in medicine it is used to quiet overactive nerve signals and relax tight tissues. The second treatment is Qutenza, a prescription skin patch that delivers capsaicin—the compound that makes chilli peppers hot—directly to the painful area to desensitise sensitive nerve endings.
During the study, researchers will compare how well both treatments reduce pain scores, how long the relief lasts, and what side effects occur. They will also look at whether the treatments reduce the need for everyday pain medicines. By comparing these therapies directly, the study aims to help NHS doctors make better, evidence-based choices for women living with persistent post-surgery pain.
Key takeaways
- The trial compares Xeomin injections and Qutenza skin patches for persistent breast surgery pain.
- It is open to women aged 18 and older experiencing nerve pain after a mastectomy.
- Both treatments aim to calm irritated nerves and lower the need for daily painkillers.
- Participation is entirely voluntary, and you can withdraw at any point.
Who may be eligible?
This trial is open to adult women aged 18 and over who have long-lasting pain following breast removal surgery (mastectomy). The pain may feel like burning, sharp stabbing, deep pressure, or unusual numbness around the chest wall, scar, or armpit area.
Because this is a focused pilot study, doctors will look closely at your medical history to ensure either treatment is safe for you. Women who are pregnant, breastfeeding, or who have known allergies to botulinum toxin or chilli peppers will generally not be able to take part.
If you are currently taking other pain relief medicines, the study team will review these with you. You may still be able to join, as the researchers also want to see if the study treatments reduce the need for other pain tablets.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am a woman aged 18 or older.
- I have had a mastectomy (breast removal surgery).
- I have ongoing pain, burning, stabbing, or numbness near my surgery scar.
- I am willing to attend clinic visits and record my pain levels.
- I am not allergic to botulinum toxin or chilli peppers.
What does participation involve?
If you decide to take part, you will first attend a screening visit where the medical team will examine your surgical scar and review your general health. You will then be randomly assigned (like flipping a coin) to receive either the Xeomin injections or the Qutenza skin patch applied to the painful area.
During the trial, you will be asked to rate your pain using simple scoring scales and describe what it feels like (for example, whether it is burning or stabbing). You will also record any side effects and note down any other painkillers you take. The study involves regular check-ins over several weeks or months to see how long any pain relief lasts. Your clinic team will explain the exact schedule of visits before you agree to join.
Potential risks and benefits
Locations (1)
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Common questions
What is postmastectomy pain syndrome?
It is a type of long-term nerve pain that can develop in the chest, armpit, or arm after breast cancer surgery, often causing burning or stabbing sensations.
Can I choose which treatment I receive?
No. A computer randomly decides whether you receive the injection or the skin patch, which ensures the test results are fair and unbiased.
Will the treatments hurt?
The injections involve tiny needles that can pinch briefly. The capsaicin patch often causes a warm, burning, or stinging sensation on the skin, which settles down after treatment.
Can I still take my regular painkillers?
Yes, although the study team will ask you to keep a record of all medicines you take so they can measure any changes.
What happens if I change my mind?
You can leave the study at any point. Your decision will not affect the standard of care or kindness you receive from your doctors.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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