Clinical trial NCT03317613: Clinical Trial Assessing the Efficacy of Capsaicin Patch (Qutenza®) in Cancer Patients With Neuropathic Pain
Official title: Clinical Trial Assessing the Efficacy of Capsaicin Patch (Qutenza®) in Cancer Patients With Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neuropathic Pain
Keywords: Neuropathic Pain
Qutenza
Capsaicin
Cancer patient
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Institut de Cancérologie de la Loire
First posted: 2017-10-23
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Cancer patients treated with qutenza (capsaicin patch)
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of responders to capsaicin
timeFrame: One month
Secondary outcomes:
measure: Maximum value of relief
timeFrame: Three months
measure: Correlation coefficient between the relief score and time before first relief
timeFrame: Three months
measure: Neuropathic pain intensity reported on visual analog scale
timeFrame: One year
measure: Number of toxicities reported
timeFrame: One year
measure: Number of days of response
timeFrame: One year
measure: Number of days of response to qutenza
timeFrame: One year
measure: Size of painful zones
timeFrame: One year
measure: Number of prescribed antalgics
timeFrame: One year
measure: Percentage of patients with a reported chemotherapy
timeFrame: One year
measure: Percentage of patients who have received at least 75% of the chemotherapy prescribed
timeFrame: One year
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Le Puy-en-Velay
country: France
facility: Centre Hospitalier Emile Roux
city: Saint-Priest-en-Jarez
country: France
facility: Institut de Cancérologie Lucien Neuwirth
Study officials:
affiliation: Institut de Cancérologie Lucien Neuwirth
name: Stéphanie Morisson, MD
role: PRINCIPAL_INVESTIGATOR
References: