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

Neuropathic Pain Clinical Trial

— CAPSONCO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03317613
• Other study ID #: 2017-0304
• Secondary ID: 2017-002476-11
• Status: Completed
• Phase: Phase 2
• Start date: November 9, 2017
• Est. completion date: December 20, 2021

Study information

• Verified date: February 2022
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: December 20, 2021
• Est. primary completion date: December 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Intervention

Drug:
• Qutenza
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.

Locations

Country	Name	City	State
France	Centre Jean Perrin	Clermont-Ferrand
France	Centre Hospitalier Emile Roux	Le Puy-en-Velay
France	Institut de Cancérologie Lucien Neuwirth	Saint-Priest-en-Jarez

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Institut de Cancérologie de la Loire

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Number of toxicities reported	Capsaicin patch induced toxicities will be reported, and quoted according to CTCAE version 4.4.	One year
Secondary	Number of days of response	Number of days of response reported by patients where patch are efficient will be reported	One year
Secondary	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
Secondary	Size of painful zones	Size of painful zones will be reported.	One year
Secondary	Number of prescribed antalgics	Number of prescribed antalgics will be reported for each patient.	One year
Secondary	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
Secondary	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