Clinical Trial Assessing the Efficacy of Capsaicin Patch (Qutenza®) in Cancer Patients With Neuropathic Pain

Study Overview
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Brief Summary
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In the oncology area, neuropathic pains are relatively frequent and can be induced by surgery, radiotherapy, or chemotherapy. In usual practice, some units are using qutenza in order to reduce neuropathic pain even though using of this patch for a population of cancer patients has never been demonstrated so far in a prospective study. The present prospective study proposes to evaluate the qutenza efficacy in peripheric neuropathic pain in cancer patients.

Detailed Description
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Drugs for neuropathic pains are generally represented by antidepressants, anti-epileptics, opioids, lidocaine patch. However, these drugs can frequently be insufficient, and/or can lead to side effects. Qutenza (8% capsaicin patch) presents an interesting alternative. Qutenza efficacy has been shown in five principal studies conducted on 1988 adults affected by moderate or severe neuropathic pains. All patients presented Postherpetic neuralgia, or HIV associated therapy, or painful diabetic peripheric neuropathies. These studies led to qutenza approbation in Europe and in States in 2009. In oncology, neuropathic pains are relatively frequent and can be induced by the three big actors of the anti-cancerous therapeutic arsenal (surgery, radiotherapy, chemotherapy). In usual practice, some units are usually using qutenza, but the use of this patch for this kind of patients has not been shown in a prospective study. Advantages of this treatment are numerous, and results presented in other therapeutic area are encouraging its use in oncology. The present prospective study proposes to evaluate the qutenza efficacy in peripheric neuropathic pain in cancer patients.

Official Title
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Clinical Trial Assessing the Efficacy of Capsaicin Patch (Qutenza®) in Cancer Patients With Neuropathic Pain

Conditions
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Neuropathic Pain

Intervention / Treatment
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* Drug: Qutenza


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with at least 18 years old; Patient presenting neuropathic pain secondary to an anti-cancerous treatment; Patient presenting a DN4 (Neuropathic Pain in Four Questions) score superior or equal to 4 out of 10 Patient presenting a skin without lesion at the painful area Informed consent form signed; Patient affiliated to a social security scheme. Exclusion Criteria: Hypersensitivity known to capsaicin; Instable or uncontrolled hypertension; Painful area localised next to eyes; Pregnant or breastfeeding woman; Protected people.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Cancer patients treated with qutenza (capsaicin patch)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Capsaicin<br>Cancer patients presenting neuropathic pain secondary to their anti cancer treatments will receive patch of capsaicin (qutenza) on the painful zones.. | Drug: Qutenza<br>* Patients suffering from neuropathic pain will receive patch of capsaicin (qutenza) on the painful zones. Three months after the first application, patients will be allowed to receive another patch if necessary. They will be able to receive one every three months. They will be followed in the study during one year after the first patch application.<br>* Other names: 8% capsaicin patch;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of responders to capsaicin | Percentage of responders to capsaicin at one month after the first patch application will be calculated with a relief scale completed by patients. | One month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum value of relief | Maximum value of relief will be calculated for patients with relief scale completed by patients at three months after the patch application. | Three months | 
| Correlation coefficient between the relief score and time before first relief | Correlation coefficient between maximal value of relief and time between the beginning of painful signs and first patch application. | Three months | 
| Neuropathic pain intensity reported on visual analog scale | Minimal, average, and maximal values of neuropathic pain reported on visual analog scale will be evaluated. | One year | 
| Number of toxicities reported | Capsaicin patch induced toxicities will be reported, and quoted according to CTCAE version 4.4. | One year | 
| Number of days of response | Number of days of response reported by patients where patch are efficient will be reported | One year | 
| Number of days of response to qutenza | Number of days between the patch set and the apparition of the first effect on patients will be reported. | One year | 
| Size of painful zones | Size of painful zones will be reported. | One year | 
| Number of prescribed antalgics | Number of prescribed antalgics will be reported for each patient. | One year | 
| Percentage of patients with a reported chemotherapy | Percentage of patients with an obligation to report their chemotherapy because of the pain will be calculated. | One year | 
| Percentage of patients who have received at least 75% of the chemotherapy prescribed | Percentage of patients who have received at least 75% of the chemotherapy prescribed will be reported. | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuropathic Pain, Qutenza, Capsaicin, Cancer patient