(LAX) A Randomized, open label, Non-inferiority trial on the efficacy of Lacosamide versus Duloxetine in Patients with Chemotherapy-induced Polyneuropathy - A strategy trial
This study, called LAX, is looking into how well two different medications, called Cymbalta (duloxetine) and Vimpat (lacosamide), work for patients who have nerve pain after chemotherapy treatment. This type of pain is often called chemotherapy-induced polyneuropathy. The main goal is to see if Vimpat is at least as effective as Cymbalta in reducing pain. Researchers will measure how much pain patients feel during the last four weeks of treatment. They will also look at how satisfied patients are with their treatment and any side effects they experience. Participants will be adults aged 18 or older, and both men and women can take part. This is a real-world study, meaning it's looking at how these medicines work in typical use.
At a glance
What is this study about?
Many people who have chemotherapy for cancer can experience nerve pain, especially in their hands and feet. This is called chemotherapy-induced polyneuropathy and can be very uncomfortable. We already know that a medicine called Cymbalta (duloxetine) can help with this pain.
The LAX study is designed to compare Cymbalta with another medicine called Vimpat (lacosamide). The main question researchers want to answer is whether Vimpat is just as good as, or 'non-inferior' to, Cymbalta in easing this type of nerve pain. This means they want to see if it works at least as well, which could give doctors and patients more choices for managing pain.
Taking part in this study would involve trying one of these medicines. The main thing they will measure is your pain levels over the last four weeks of the treatment. They will also ask about how happy you are with your treatment and keep track of any side effects you might have. This is a 'Phase IV' study, which means both medicines are already approved and in general use, but researchers are looking closely at how they compare for this specific condition in a real-world setting.
Key takeaways
- Compares two existing medicines, Cymbalta and Vimpat, for chemotherapy-induced nerve pain.
- Aims to see if Vimpat is as effective as Cymbalta.
- Participation involves taking one of the medicines and regular check-ups.
- Focuses on pain relief, patient satisfaction, and side effects.
- Suitable for adults aged 18 and over with this specific type of pain.
- You can withdraw from the study at any time.
Who may be eligible?
To be able to join this study, you would need to be an adult, aged 18 years or older. Both men and women are welcome to take part.
You would also need to have nerve pain that developed because of chemotherapy treatment. The doctors running the study will carefully check your medical history to make sure that the pain you are experiencing is indeed chemotherapy-induced polyneuropathy and that it meets all the specific requirements for the study.
There might be other health conditions or medications that could prevent you from joining, to ensure your safety and the accuracy of the study results. The study team will discuss all these details with you.
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.
- Are you 18 years old or older?
- Have you had chemotherapy treatment?
- Are you experiencing nerve pain that you believe is due to your chemotherapy?
- Are you willing to take one of the two study medications?
What does participation involve?
If you decide to join this study, you will be given either Cymbalta or Vimpat. You'll take this medicine for a set period. Throughout the study, you'll have regular visits to the clinic or communicate with the study team. During these visits, doctors and nurses will assess your pain levels, ask about any side effects you might be experiencing, and check on how you're generally feeling. You'll likely be asked to complete questionnaires about your pain and how satisfied you are with your treatment. The study will focus on your pain intensity during the last four weeks of treatment. The total duration of your participation, including follow-up appointments, will be explained fully by the study team.
Potential risks and benefits
Locations (1)
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Common questions
What is chemotherapy-induced polyneuropathy?
It's nerve damage and pain, often in the hands and feet, that can happen after chemotherapy treatment for cancer.
What kind of medicines are being tested?
The study is comparing two approved medicines: Cymbalta (duloxetine) and Vimpat (lacosamide), which are both used to treat pain and nerve conditions.
What does 'non-inferiority' mean in this study?
It means the study aims to see if Vimpat works at least as well as Cymbalta in treating your pain, not necessarily if it's better.
Will I know which medicine I'm taking?
This is an 'open label' study, which means both you and the study team will know which of the two medicines you are receiving.
Is this a new medicine?
No, both medicines in this study are already approved and in use. This study is looking at how they compare for this specific type of pain.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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