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Study on Capsaicin Patch and Amitriptyline for Neuropathic Pain in Head and Neck Cancer Patients in Remission

Verified siteRegistered drugNo placebo

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What is this trial about?

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

This clinical trial is focused on patients who have had head and neck cancer and are now in remission, meaning their cancer is not currently progressing. These patients often experience a type of pain called neuropathic pain, which is pain caused by nerve damage. The study is testing two treatments to see which is more effective in reducing this pain. One treatment is a patch called Qutenza, which contains the active ingredient capsaicin. Capsaicin is a substance found in chili peppers that can help relieve pain when applied to the skin. The other treatment is an oral solution called Laroxyl, which contains the active ingredient amitriptyline, a medication commonly used to treat nerve pain.

The purpose of the study is to compare the effectiveness of the capsaicin patch with the amitriptyline solution in reducing pain in the cervico-facial area, which is the neck and face region. Participants will receive either the capsaicin patch or the amitriptyline solution over a period of nine months. The capsaicin patch will be applied every three months, while the amitriptyline solution will be taken orally. Some participants may receive a placebo, which is a treatment with no active medication, to help researchers understand the true effects of the treatments being tested.

Throughout the study, participants will be monitored to see if their pain decreases by at least two points on a pain scale over the nine-month period. The study will also assess any side effects from the treatments and how the treatments impact the participants' quality of life. This information will help determine which treatment is more effective for managing neuropathic pain in patients who have had head and neck cancer.

The research process

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

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying that the patient is at least 18 years old, has head and neck cancer in remission, and experiences neuropathic pain in the cervico-facial area.
The pain must have persisted for more than 3 months after surgical or radiotherapy treatment, with a score of 4 or higher on the DN4 questionnaire and an average intensity of 2 or higher on a numerical scale over the last 24 hours.
Step 2
Treatment allocation
Patients are randomly assigned to one of two treatment groups. One group receives a capsaicin patch (Qutenza 179 mg) applied to the skin every 3 months. The other group receives amitriptyline (Laroxyl 40 mg/mL) as an oral solution.
Step 3
Treatment administration
For the capsaicin patch group, the patch is applied to the cervico-facial area every 3 months. The application is performed by a healthcare professional.
For the amitriptyline group, the oral solution is taken as prescribed by the healthcare provider. The dosage and frequency are determined based on individual patient needs.
Step 4
Follow-up assessments
Regular follow-up assessments are conducted to monitor pain levels, using a numerical scale to evaluate any changes in pain intensity.
The primary goal is to achieve a reduction in average pain by 2 points at 9 months compared to the start of the study.
Step 5
Quality of life and safety evaluations
Quality of life is assessed using the EORTC QLQ-C30 questionnaire, which evaluates various aspects of daily living.
Safety evaluations include monitoring for any adverse reactions to the treatments, using standardized criteria.
Step 6
Study completion
The study is expected to conclude by August 15, 2025. Final assessments will determine the overall effectiveness of the treatments in reducing neuropathic pain and improving quality of life.

Who can join the trial?

8 criteria

Must be **18 years or older**.
Must have **head and neck cancer** that is in **remission**, meaning there are no signs of the cancer getting worse for at least 3 months after finishing specific treatments.
Must have **pain in the head and neck area** that has lasted for more than 3 months after surgery or radiation treatment.
The pain must be of a **neuropathic nature**, which means it is related to nerve damage, and must score **4 out of 10 or higher** on a specific questionnaire called the **DN4**.
The average pain intensity over the last 24 hours must be **2 out of 10 or higher** on a numerical scale.
If the patient is a woman who has gone through **menopause**, or if not, she must agree to use **effective birth control** during the study and for at least 15 days after the study ends. Women who have not gone through menopause must have a **negative pregnancy test** before joining the study.
Must be **affiliated with a Social Health Insurance** in France.
Must have **signed an informed consent** form before joining the study and before any specific study procedures are done.

Who cannot join the trial?

7 criteria

Patients who are not in remission from head and neck cancer cannot participate.
Patients who do not have neuropathic pain, which is a type of pain caused by nerve damage, are excluded.
Patients who are under 18 years old or over 65 years old are not eligible.
Patients who are part of a vulnerable population, meaning they might need special protection or care, are not included.
Patients who are not able to follow the study procedures or instructions cannot take part.
Patients who are currently using other treatments that might interfere with the study medication are excluded.
Patients who have allergies or reactions to the study medication or similar treatments cannot participate.

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Verified sites

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Institut de Cancérologie de l'Ouest
Verified
Saint-Herblain, France
Oncopole Claudius Regaud
Verified
Toulouse, France

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Investigated drugs

Qutenza
is a patch that contains capsaicin, which is a substance found in chili peppers. It is used to relieve pain by reducing the sensitivity of pain receptors in the skin. In this trial, Qutenza is applied to the cervico-facial area of patients who have neuropathic pain after being treated for ORL (ear, nose, and throat) cancer.
Amitriptyline
is a medication commonly used to treat neuropathic pain. It works by affecting the balance of certain natural chemicals (neurotransmitters) in the brain. In this study, amitriptyline serves as a reference treatment to compare its effectiveness against the capsaicin patch in managing pain for patients in remission from ORL cancer.

What is already known about the treatment

Qutenza – This medication is administered as a patch applied directly to the skin. It is currently being studied in clinical trials for its effectiveness in treating neuropathic pain in patients who have had head and neck cancer. The main therapeutic indication is to provide pain relief for neuropathic pain in the cervico-facial area. Qutenza works by delivering capsaicin, which interacts with nerve receptors to reduce pain signals. It is classified as a topical analgesic.

Investigated diseases

Head and Neck Cancer – This type of cancer originates in the squamous cells that line the moist surfaces inside the head and neck, such as the mouth, nose, and throat. It can also develop in the salivary glands, although this is less common. The disease often begins as a small, painless growth or sore that does not heal. As it progresses, it may cause symptoms like a persistent sore throat, difficulty swallowing, or changes in the voice. Swelling or lumps in the neck area can also occur as the cancer advances. Early detection is crucial for managing the disease effectively.