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

Centre Hospitalier Universitaire de Saint Etienne

Status and phase: Completed; Phase 2

Conditions: Neuropathic Pain

Treatments: Drug: Qutenza

Study type: Interventional

Funder types: Other

Identifiers

NCT03317613

2017-002476-11 (EudraCT Number)

2017-0304

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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84 participants in 1 patient group

Capsaicin

Experimental group

Description:

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

Treatment:

Drug: Qutenza