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

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.

Study Overview

• Status: Completed
• Conditions: Neuropathic Pain
• Intervention / Treatment: Drug: Qutenza

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.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63000
    • Centre Jean Perrin
  • Le Puy-en-Velay, France, 43000
    • Centre Hospitalier Emile Roux
  • Saint-Priest-en-Jarez, France, 42271
    • institut de cancérologie Lucien Neuwirth

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Capsaicin; Cancer patients presenting neuropathic pain secondary to their anti cancer treatments will receive patch of capsaicin (qutenza) on the painful zones..	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: Institut de Cancérologie de la Loire
• Investigators: Principal Investigator: Stéphanie Morisson, MD, institut de cancérologie Lucien Neuwirth

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2017
• Primary Completion (Actual): December 4, 2020
• Study Completion (Actual): December 20, 2021

Study Registration Dates

• First Submitted: September 21, 2017
• First Submitted That Met QC Criteria: October 20, 2017
• First Posted (Actual): October 23, 2017

Study Record Updates

• Last Update Posted (Actual): February 8, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Neuropathic Pain; Capsaicin; Qutenza; Cancer patient
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Dermatologic Agents; Antipruritics; Capsaicin
• Other Study ID Numbers: 2017-0304; 2017-002476-11 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No