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

NCT03317613 | Completed Phase 2

• 2 other identifiers: 2017-03042017-002476-11
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 3

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.

Conditions

Neuropathic Pain

Keywords

Neuropathic Pain; Qutenza; Capsaicin; Cancer patient

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Maximum value of relief

  Three months

• Correlation coefficient between the relief score and time before first relief

  Three months

• Neuropathic pain intensity reported on visual analog scale

  One year

• Number of toxicities reported

  One year

• Number of days of response

  One year

Study Arms (1)

Capsaicin

EXPERIMENTAL

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

Drug: Qutenza

Interventions

Qutenza 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.

Also known as: 8% capsaicin patch

Capsaicin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Hypersensitivity known to capsaicin;
• Instable or uncontrolled hypertension;
• Painful area localised next to eyes;
• Pregnant or breastfeeding woman;
• Protected people.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Institut de Cancérologie de la Loire: collaborator

Study Sites (3)

Centre Jean Perrin

Clermont-Ferrand, 63000, France

Location

Centre Hospitalier Emile Roux

Le Puy-en-Velay, 43000, France

Location

Institut de Cancérologie Lucien Neuwirth

Saint-Priest-en-Jarez, 42271, France

Location

MeSH Terms

Conditions

Neuralgia

Interventions

Capsaicin

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Study Officials

• Stéphanie Morisson, MD

  Institut de Cancérologie Lucien Neuwirth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cancer patients treated with qutenza (capsaicin patch)

Study Record Dates

• First Submitted: September 21, 2017
• First Posted: October 23, 2017
• Study Start: November 9, 2017
• Primary Completion: December 4, 2020
• Study Completion: December 20, 2021
• Last Updated: February 8, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)