Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Phase II Randomized Controlled Study Aiming to Evaluate the Interest of Qutenza in Patients With ORL Cancer in Remission and With Sequellae Neuropathic Pain.

This research study is for people who have successfully been treated for head and neck cancer but are still experiencing ongoing nerve pain. Nerve pain can be very uncomfortable, and this study aims to find out if a special skin patch called Qutenza (which contains a chili pepper extract) can help reduce it. We're comparing Qutenza with a liquid medicine called Laroxyl to see which works better at lowering pain levels over a nine-month period. We'll be checking how much pain people feel, how their quality of life changes, and if there are any side effects from the treatments. The main goal is to see if these treatments can significantly ease pain for patients.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Oncopole Claudius Regaud

Enrolment target

130

Start

13 Aug 2024

Head and neck cancer

What is this study about?

If you've had head and neck cancer, even after successful treatment, you might sometimes experience ongoing nerve pain. This type of pain can be very challenging to live with and can affect your daily life. Doctors and researchers are always looking for better ways to help people manage this pain.

This study is designed to explore whether two different treatments can help ease this nerve pain. One treatment is a special skin patch called Qutenza, which contains a substance derived from chili peppers known to help with nerve pain. The other treatment is a liquid medicine called Laroxyl. The study wants to see both if these treatments work and how well they compare to each other.

The main thing we want to find out is if people taking part in the study feel a noticeable reduction in their pain levels over a period of nine months. We'll also be looking at how these treatments affect quality of life and if there are any unwanted side effects, all while keeping a close eye on how you're feeling.

Key takeaways

This study tests treatments for nerve pain after head and neck cancer.
It compares a skin patch (Qutenza) with a liquid medicine (Laroxyl).
The main aim is to see if pain is reduced after nine months.
Your quality of life and any side effects will also be checked.
The study is for adults who have current nerve pain from treated head and neck cancer.

Who may be eligible?

This study is open to adults aged 18 and over, regardless of whether they are male or female.

To join, you must have previously been treated for head and neck cancer and now be in remission, meaning your cancer is under control. You also need to be experiencing nerve pain as a result of your past cancer treatment. The doctors will check your specific situation to make sure this study is right for you, and that it's safe for you to take part.

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 been treated for head and neck cancer in the past?
Is your cancer currently in remission (under control)?
Are you currently experiencing nerve pain as a result of your cancer treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given either the Qutenza skin patch or the Laroxyl liquid medicine. You won't know which one you're receiving, but your study team will. You'll have regular visits over nine months during which your pain levels will be carefully monitored using simple questionnaires and scales. We'll also ask questions about your general well-being and any side effects you might experience. It's important to stick to the study schedule and report any changes in your health or other medicines you might be taking.

Potential risks and benefits

Taking part in this study may offer the potential benefit of finding a treatment that significantly reduces your nerve pain, which could improve your quality of life. However, as with any medicine, there is a risk of side effects from both Qutenza and Laroxyl. These will be carefully explained to you by the study team. You are completely free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is nerve pain?

Nerve pain is pain caused by damage to your nerves. It can feel like burning, tingling, shooting, or electric shocks.

What is Qutenza?

Qutenza is a skin patch that contains capsaicin, a substance found in chili peppers. It works by affecting the pain signals sent by nerves.

What is Laroxyl?

Laroxyl is a liquid medicine (which generally contains amitriptyline) that can sometimes be used to help with nerve pain, among other things.

Will I know which treatment I'm getting?

No, this is a 'blinded' study, meaning neither you nor your doctor will know whether you are receiving Qutenza or Laroxyl. This helps make the study results more reliable.

How long does the study last?

The main part of the study where your pain is measured will last for nine months.