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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
84
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.
Centre Jean Perrin
Clermont-Ferrand, France
Centre Hospitalier Emile Roux
Le Puy-en-Velay, France
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, France
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.
Time frame: One month
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.
Time frame: 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.
Time frame: 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.
Time frame: One year
Number of toxicities reported
Capsaicin patch induced toxicities will be reported, and quoted according to CTCAE version 4.4.
Time frame: One year
Number of days of response
Number of days of response reported by patients where patch are efficient will be reported
Time frame: 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.
Time frame: One year
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Size of painful zones
Size of painful zones will be reported.
Time frame: One year
Number of prescribed antalgics
Number of prescribed antalgics will be reported for each patient.
Time frame: 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.
Time frame: 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.
Time frame: One year