CAPSONCO: Clinical Trial Assessing the Efficacy of Capsaicin Patch (Qutenza®) in Cancer Patients With Neuropathic Pain
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
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 Design
Arms and Interventions
| 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:
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Outcome Measures
Primary Outcome Measures
- Percentage of responders to capsaicin [One month]
Percentage of responders to capsaicin at one month after the first patch application will be calculated with a relief scale completed by patients.
Secondary Outcome Measures
- Maximum value of relief [Three months]
Maximum value of relief will be calculated for patients with relief scale completed by patients at three months after the patch application.
- Correlation coefficient between the relief score and time before first relief [Three months]
Correlation coefficient between maximal value of relief and time between the beginning of painful signs and first patch application.
- Neuropathic pain intensity reported on visual analog scale [One year]
Minimal, average, and maximal values of neuropathic pain reported on visual analog scale will be evaluated.
- Number of toxicities reported [One year]
Capsaicin patch induced toxicities will be reported, and quoted according to CTCAE version 4.4.
- Number of days of response [One year]
Number of days of response reported by patients where patch are efficient will be reported
- Number of days of response to qutenza [One year]
Number of days between the patch set and the apparition of the first effect on patients will be reported.
- Size of painful zones [One year]
Size of painful zones will be reported.
- Number of prescribed antalgics [One year]
Number of prescribed antalgics will be reported for each patient.
- Percentage of patients with a reported chemotherapy [One year]
Percentage of patients with an obligation to report their chemotherapy because of the pain will be calculated.
- Percentage of patients who have received at least 75% of the chemotherapy prescribed [One year]
Percentage of patients who have received at least 75% of the chemotherapy prescribed will be reported.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patient with at least 18 years old;
-
Patient presenting neuropathic pain secondary to an anti-cancerous treatment;
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Patient presenting a DN4 (Neuropathic Pain in Four Questions) score superior or equal to 4 out of 10
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Patient presenting a skin without lesion at the painful area
-
Informed consent form signed;
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Patient affiliated to a social security scheme.
Exclusion Criteria:
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Hypersensitivity known to capsaicin;
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Instable or uncontrolled hypertension;
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Painful area localised next to eyes;
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Pregnant or breastfeeding woman;
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Protected people.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre Jean Perrin | Clermont-Ferrand | France | 63000 | |
| 2 | Centre Hospitalier Emile Roux | Le Puy-en-Velay | France | 43000 | |
| 3 | Institut de Cancérologie Lucien Neuwirth | Saint-Priest-en-Jarez | France | 42271 |
Sponsors and Collaborators
- Centre Hospitalier Universitaire de Saint Etienne
- Institut de Cancérologie de la Loire
Investigators
- Principal Investigator: Stéphanie Morisson, MD, Institut de Cancérologie Lucien Neuwirth
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2017-0304
- 2017-002476-11