Trial | NCT03317613  Report issue

Official Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    84
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 Started
Nov 09
2017
Primary Completion
Dec 04
2020
Study Completion
Dec 20
2021
Last Update
Feb 08
2022

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.

  • Other names: 8% capsaicin patch

Capsaicin Experimental

Cancer patients presenting neuropathic pain secondary to their anti cancer treatments will receive patch of capsaicin (qutenza) on the painful zones..

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.
No Results Posted