Neuropathic PainPhase 2CAPSONCONCT03317613
Clinical Trial Assessing the Efficacy of Capsaicin Patch (Qutenza®) in Cancer Patients With Neuropathic Pain
A Phase 2 study testing Qutenza in people with Neuropathic Pain, run by Centre Hospitalier Universitaire de Saint Etienne at 3 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- Qutenza
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 3 sitesFrance
- Study dates
- 9 Nov 2017to 20 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Hypersensitivity known to capsaicin;
- Instable or uncontrolled hypertension;
- Painful area localised next to eyes;
- Pregnant or breastfeeding woman;
- Protected people.
Trial locations and contacts
3 sites in 1 country.
France3 sites
Centre Jean Perrin
Clermont-Ferrand, 63000
Centre Hospitalier Emile Roux
Le Puy-en-Velay, 43000
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, 42271
About this study
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.
Read the 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
- Being tested
- Qutenza
- Keywords
- Neuropathic Pain, Qutenza, Capsaicin, Cancer patient
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QutenzaDrug
Also called 8% capsaicin patch
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.
| Study group | Role | What they receive |
|---|---|---|
| Capsaicin | Experimental | Cancer patients presenting neuropathic pain secondary to their anti cancer treatments will receive patch of capsaicin (qutenza) on the painful zones.. Receives: Drug: Qutenza |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One month
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: One year
Number of toxicities reported
Capsaicin patch induced toxicities will be reported, and quoted according to CTCAE version 4.4.
Measured: One year
Number of days of response
Number of days of response reported by patients where patch are efficient will be reported
Measured: 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.
Measured: One year
Size of painful zones
Size of painful zones will be reported.
Measured: One year
Number of prescribed antalgics
Number of prescribed antalgics will be reported for each patient.
Measured: 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.
Measured: 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.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start9 Nov 2017
- Primary completion4 Dec 2020
- Study completion20 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Cancer patients treated with qutenza (capsaicin patch)
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Cancérologie de la Loire
- Responsible party
- Sponsor
- Investigators
- Stéphanie Morisson, MD, Principal investigator, Institut de Cancérologie Lucien Neuwirth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03317613
- Sponsor's protocol ID
- 2017-0304
- Other IDs
- 2017-002476-11, 2017
- Acronym
- CAPSONCO
- Status last verified
- Feb 2022
- First submitted
- 21 Sep 2017
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial Assessing the Efficacy of Capsaicin Patch (Qutenza®) in Cancer Patients With Neuropathic Pain
- ClinicalTrials.gov ID
- NCT03317613
- Acronym / sponsor ID
- CAPSONCO / 2017-0304
- Conditions
- Neuropathic Pain
- Keywords
- Neuropathic Pain, Qutenza, Capsaicin, Cancer patient
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Institut de Cancérologie de la Loire
- Study start
- 9 Nov 2017 (actual)
- Primary completion
- 4 Dec 2020 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 23 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cancer patients treated with qutenza (capsaicin patch)
| Arm | Type | Receives |
|---|---|---|
| Capsaicin | Experimental | Drug: QutenzaCancer patients presenting neuropathic pain secondary to their anti cancer treatments will receive patch of capsaicin (qutenza) on the painful zones.. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- Hypersensitivity known to capsaicin;
- Instable or uncontrolled hypertension;
- Painful area localised next to eyes;
- Pregnant or breastfeeding woman;
- Protected people.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QutenzaAlso: 8% capsaicin patchPatients 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. | Drug | Capsaicin |
Primary outcome
Percentage of responders to capsaicin
Time frame: 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.
10 secondary outcomes
Maximum value of relief
Time frame: Three months
Correlation coefficient between the relief score and time before first relief
Time frame: Three months
Neuropathic pain intensity reported on visual analog scale
Time frame: One year
Number of toxicities reported
Time frame: One year
Number of days of response
Time frame: One year
Number of days of response to qutenza
Time frame: One year
Size of painful zones
Time frame: One year
Number of prescribed antalgics
Time frame: One year
Percentage of patients with a reported chemotherapy
Time frame: One year
Percentage of patients who have received at least 75% of the chemotherapy prescribed
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stéphanie Morisson, MD principal investigator
Institut de Cancérologie Lucien Neuwirth
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Qutenza in people with Neuropathic Pain, run by Centre Hospitalier Universitaire de Saint Etienne at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of responders to capsaicin (time frame: One month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2022; AzTrials last refreshed its copy on 8 Nov 2026.