Neuropathic Pain Clinical Trial
— CAPSONCOOfficial title:
Clinical Trial Assessing the Efficacy of Capsaicin Patch (Qutenza®) in Cancer Patients With Neuropathic Pain
Verified date | February 2022 |
Source | Centre Hospitalier Universitaire de Saint Etienne |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 84 |
Est. completion date | December 20, 2021 |
Est. primary completion date | December 4, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | Centre Jean Perrin | Clermont-Ferrand | |
France | Centre Hospitalier Emile Roux | Le Puy-en-Velay | |
France | Institut de Cancérologie Lucien Neuwirth | Saint-Priest-en-Jarez |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Saint Etienne | Institut de Cancérologie de la Loire |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Number of toxicities reported | Capsaicin patch induced toxicities will be reported, and quoted according to CTCAE version 4.4. | One year | |
Secondary | Number of days of response | Number of days of response reported by patients where patch are efficient will be reported | One year | |
Secondary | 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 | |
Secondary | Size of painful zones | Size of painful zones will be reported. | One year | |
Secondary | Number of prescribed antalgics | Number of prescribed antalgics will be reported for each patient. | One year | |
Secondary | 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 | |
Secondary | 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 |
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