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

NCT ID: NCT03317613

Last Updated: 2022-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-09
• Study Completion Date: 2021-12-20

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.

Conditions

Neuropathic Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Capsaicin

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

Group Type: EXPERIMENTAL

Qutenza

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

8% capsaicin patch

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut de Cancérologie de la Loire

OTHER

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stéphanie Morisson, MD

Role: PRINCIPAL_INVESTIGATOR

Institut de Cancérologie Lucien Neuwirth

Locations

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

Countries

France

Other Identifiers

2017-002476-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2017-0304

Identifier Type: -

Identifier Source: org_study_id