Chemotherapy-induced Peripheral NeuropathyPhase 3CAPNEUCHIMNCT05840562
Capsaicin 179 mg Patch Versus Oral Duloxetine in Patients With Chemotherapy-induced Peripheral Neuropathy
A Phase 3 study testing Capsaicin and Duloxetine in people with Chemotherapy-induced Peripheral Neuropathy, run by Institut Cancerologie de l'Ouest at 11 sites in France.
Trial summary
Chemotherapy induced peripheral neuropathy (CIPN) is a frequent and disabling complication of systemic chemotherapy, particularly with oxaliplatin or taxanes. The incidence of CIPN is variable but approximately 30-40% of patients treated with neurotoxic chemotherapy agents develop CIPN after long-term use of taxanes… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy
- What is being tested?
- Capsaicin and Duloxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- 11 sitesFrance
- Study dates
- 20 Oct 2023to Mar 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 CIPN manifested by painful symptoms such as numbness and / or tingling and / or burning pain in fingers / hands and toes / feet with a typical distribution in "gloves and socks" beginning after neurotoxic chemotherapy
- Painful CIPN as expressed by the BPI-SF (average pain) as ≥ 4/10
- CIPN persisting at least 1 month after completion of chemotherapy with taxanes and/or platinum salts and sensory CIPN grade ≥ 2 according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE v.5.0) grading scale
- Stable doses in the 4 weeks before screening, of concomitant neuropathic pain medication (antiepileptic drugs)
- Healthy and non-irritated skin on the areas to be treated
- Absence of neurotoxic chemotherapy planned during the next 6 months after inclusion
Show all 9Show fewer
- Patient affiliated to a social security scheme
- > 18 years old
- Signed written informed consent form
Who cannot join
- Presence of known carcinomatous meningitis
- Pre-existing known peripheral neuropathy of another aetiology (alcohol, diabetes, …)
- Hypersensitivity to Capsaicin or contra-indications to duloxetine (e.g imatinib, tamoxifen)
- Patient already treated for this neuropathy with Capsaicin patches
- Patient treated by antidepressant drugs at time of inclusion
- Uncontrolled hypertension (systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 90 mmHg) or recent history (<3 months) of cardiovascular events (stroke, heart attack, pulmonary embolism)
Show all 10Show fewer
- Patients with known severe renal or hepatic failure
- Breastfeeding or pregnant women
- Persons deprived of liberty or guardianship (including curatorship)
- Patient unable to undergo regular medical follow-up for geographical, social or psychological.
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Marine TIGREAT contact
11 sites in 1 country
France11 sites, 11 recruiting
- Recruiting
Institut de Cancérologie de l'Ouest
Angers, 49055
Marine Tigreat, marine.tigreat@ico.unicancer.fr
Florent Bienfait
- Recruiting
CHU Bordeaux
Bordeaux, 33075
Fanny LAFAYE, MD, fanny.lafaye@chu-bordeaux.fr
Fanny LAFAYE, MD
- Recruiting
Centre François Baclesse
Caen, 14076
Frédérique Bisiaux, MD, f.bisiaux@baclesse.unicancer.fr
Frédérique Bisiaux
- Recruiting
CHU Grenoble
Grenoble, 38043
Caroline MAINDET, MD
Caroline MAINDET, MD
- Recruiting
Polyclinique Chenieux
Limoges, 87039
Gaelle Martine Fabre, MD, g.martine@polyclinique-limoges.fr
Gaelle Martine Fabre
- Recruiting
Centre Léon Bérard
Lyon, 69373
Olivier RENARD, MD, olivier.renard@lyon.unicancer.fr
Olivier RENARD, MD
- Recruiting
"L'Hôpital Privé du Confluent "
Nantes, 44200
Thomas CUVIER, MD
Thomas CUVIER, MD
- Recruiting
Centre Antoine Lacassagne
Nice, 06189
Anne FOGLIARINI, MD
Anne FOGLIARINI, MD
- Recruiting
Institut de Cancérologie de l'Ouest
Saint-Herblain, 44805
Marine Tigreat, marine.tigreat@ico.unicancer.fr
François Xavier Piloquet
- Recruiting
Institut de Cancérologie Strasbourg Europe
Strasbourg, 67033
Anna SCHOHN, MD, a.schohn@icans.eu
Anna SCHOHN
- Recruiting
Institut Claudius Regaud -IUCT-O
Toulouse, 31059
Antoine BODEN, MD, boden.antoine@iuct-oncopole.fr
Antoine BODEN, MD
About this study
Official title: Capsaicin 179 mg Patch Versus Oral Duloxetine in Patients With Chemotherapy-induced Peripheral Neuropathy : a Phase 3 Randomized Multicentric Open-label Study.
Chemotherapy induced peripheral neuropathy (CIPN) is a frequent and disabling complication of systemic chemotherapy, particularly with oxaliplatin or taxanes. The incidence of CIPN is variable but approximately 30-40% of patients treated with neurotoxic chemotherapy agents develop CIPN after long-term use of taxanes or oxaliplatin.
This CIPN is essentially a sensory peripheral neuropathy with pain manifested by unpleasant symptoms such as numbness, tingling, and less frequently shooting/burning pain. These symptoms spread proximally to affect both lower and upper extremities in a characteristic "stocking and glove" distribution.
Read more
Many symptoms of CIPN may resolve completely for some patients. However, CIPN is only partly reversible for most. In the worst instances, it does not appear to be reversible at all and can even increase over time.
CIPN is difficult to manage. Only duloxetine is recommended, based on the positive result of a randomized phase III double-blind placebo-controlled crossover trial. The use of duloxetine resulted in a greater reduction in pain and was effective in decreasing numbness and tingling in the feet. But, systemic antidepressants are often associated with toxicities and patients often refuse or abandon the treatment.
Capsaicin inhibits neural transmission in sensory axons and has been proven as effective on the intensity of pain for post-herpetic neuralgia and human immunodeficiency virus-associated neuropathy. Efficacy appears at one month and persists for at least 2 months.
Only a few studies focused on the efficacy of capsaicin 179 mg patch on the intensity of CIPN-induced pain. These non-randomized studies show that more than 50% of patients have a reduction in pain intensity of more than 30%.
Until now, no clinical trial has compared the efficacy of the capsaicin 179 mg patch with duloxetine.
Accordingly, this open-label phase 3, randomized, multicenter trial, will compare efficacy and safety of capsaicin patch with oral duloxetine on painful CIPN persisting more than 3 months after the end of the responsible chemotherapy.
- Being tested
- Capsaicin, Duloxetine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapsaicinDrug
Also called Qutenza
Application of capsaicin patches 179 mg
DuloxetineDrug
Also called Cymbalta
Administration of duloxetine
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | The capsaicin 179 mg patch should be applied to the most painful extremities.
Application:
* Capsaicin patches must be applied to intact, dry and non-irritated skin and allowed to remain in place for 30 minutes for the feet and maximum 60 minutes for hands depending on immediate tolerance.
* If all the areas to be treated cannot be treated in once, a second session will be organised between 3 and 7 days later. Further sessions can be held within 15 days of the 1st session (up to 4 sessions in total). All sessions will be considered as one application.
* 1 application may require several treatment sessions.
* The patch, which may be cut to shape, was used within 2 h of opening the foil pouch.
After the first treatment session, treatment may be repeated every 2 months (at weeks 9, 17, 25) as warranted by the persistence or return of pain. Receives: Drug: Capsaicin |
| Control Arm | Active comparator | Duloxetine should be initiated at an initial dose of 30 mg orally for 1 week followed by a maintenance dose of 60 mg per day, given either once a day or 30 mg orally 2 times a day.
After W6, in case of insufficient response to the 60 mg dose, the dosage may be increased to the maximum dose of 120 mg. Receives: Drug: Duloxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to demonstrate that capsaicin 179 mg patch once compared to duloxetine daily, improves painful CIPN after a 5-week treatment period.
The primary endpoint will be the percentage of painful CIPN patients experiencing a 30% improvement in their average pain severity score at 6 weeks compared to baseline (measured on day 1 of week 6).
Patient-reported pain severity will be quantified using the Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF contains four items assessing average, worst, least, and immediate pain severity in the last 24 hours. Pain severity items are scored using an 11-point numeric rating scale (0 = no pain; 10 = pain as bad as you can imagine).
In this study, we choose the "average" pain severity score as our primary outcome measure, following recommendations from the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT).
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start20 Oct 2023
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Peripheral NeuropathyStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 274 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Collaborators
- Grünenthal GmbH
- Responsible party
- Sponsor
- Investigators
- François Xavier PILOQUET, MD, Study director, Institut de Cancérologie de l'Ouest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05840562
- Sponsor's protocol ID
- ICO-2022-02
- Acronym
- CAPNEUCHIM
- Status last verified
- Mar 2026
- First submitted
- 21 Apr 2023
- Last updated
- 31 Mar 2026
- 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 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capsaicin 179 mg Patch Versus Oral Duloxetine in Patients With Chemotherapy-induced Peripheral Neuropathy : a Phase 3 Randomized Multicentric Open-label Study.
- ClinicalTrials.gov ID
- NCT05840562
- Acronym / sponsor ID
- CAPNEUCHIM / ICO-2022-02
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 274 participants (estimated)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Collaborators
- Grünenthal GmbH
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 3 May 2023 (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.
Chemotherapy induced peripheral neuropathy (CIPN) is a frequent and disabling complication of systemic chemotherapy, particularly with oxaliplatin or taxanes. The incidence of CIPN is variable but approximately 30-40% of patients treated with neurotoxic chemotherapy agents develop CIPN after long-term use of taxanes or oxaliplatin.
This CIPN is essentially a sensory peripheral neuropathy with pain manifested by unpleasant symptoms such as numbness, tingling, and less frequently shooting/burning pain. These symptoms spread proximally to affect both lower and upper extremities in a characteristic "stocking and glove" distribution.
Many symptoms of CIPN may resolve completely for some patients. However, CIPN is only partly reversible for most. In the worst instances, it does not appear to be reversible at all and can even increase over time.
CIPN is difficult to manage. Only duloxetine is recommended, based on the positive result of a randomized phase III double-blind placebo-controlled crossover trial. The use of duloxetine resulted in a greater reduction in pain and was effective in decreasing numbness and tingling in the feet. But, systemic antidepressants are often associated with toxicities and patients often refuse or abandon the treatment.
Capsaicin inhibits neural transmission in sensory axons and has been proven as effective on the intensity of pain for post-herpetic neuralgia and human immunodeficiency virus-associated neuropathy. Efficacy appears at one month and persists for at least 2 months.
Only a few studies focused on the efficacy of capsaicin 179 mg patch on the intensity of CIPN-induced pain. These non-randomized studies show that more than 50% of patients have a reduction in pain intensity of more than 30%.
Until now, no clinical trial has compared the efficacy of the capsaicin 179 mg patch with duloxetine.
Accordingly, this open-label phase 3, randomized, multicenter trial, will compare efficacy and safety of capsaicin patch with oral duloxetine on painful CIPN persisting more than 3 months after the end of the responsible chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Drug: CapsaicinThe capsaicin 179 mg patch should be applied to the most painful extremities. Application: * Capsaicin patches must be applied to intact, dry and non-irritated skin and allowed to remain in place for 30 minutes for the feet and maximum 60 minutes for hands depending on immediate tolerance. * If all the areas to be treated cannot be treated in once, a second session will be organised between 3 and 7 days later. Further sessions can be held within 15 days of the 1st session (up to 4 sessions in total). All sessions will be considered as one application. * 1 application may require several treatment sessions. * The patch, which may be cut to shape, was used within 2 h of opening the foil pouch. After the first treatment session, treatment may be repeated every 2 months (at weeks 9, 17, 25) as warranted by the persistence or return of pain. |
| Control Arm | Active comparator | Drug: DuloxetineDuloxetine should be initiated at an initial dose of 30 mg orally for 1 week followed by a maintenance dose of 60 mg per day, given either once a day or 30 mg orally 2 times a day. After W6, in case of insufficient response to the 60 mg dose, the dosage may be increased to the maximum dose of 120 mg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient with CIPN manifested by painful symptoms such as numbness and / or tingling and / or burning pain in fingers / hands and toes / feet with a typical distribution in "gloves and socks" beginning after neurotoxic chemotherapy
- Painful CIPN as expressed by the BPI-SF (average pain) as ≥ 4/10
- CIPN persisting at least 1 month after completion of chemotherapy with taxanes and/or platinum salts and sensory CIPN grade ≥ 2 according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE v.5.0) grading scale
- Stable doses in the 4 weeks before screening, of concomitant neuropathic pain medication (antiepileptic drugs)
- Healthy and non-irritated skin on the areas to be treated
Key exclusion criteria (10 listed)
- Presence of known carcinomatous meningitis
- Pre-existing known peripheral neuropathy of another aetiology (alcohol, diabetes, …)
- Hypersensitivity to Capsaicin or contra-indications to duloxetine (e.g imatinib, tamoxifen)
- Patient already treated for this neuropathy with Capsaicin patches
- Patient treated by antidepressant drugs at time of inclusion
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 |
|---|---|---|
| CapsaicinAlso: QutenzaApplication of capsaicin patches 179 mg | Drug | Experimental Arm |
| DuloxetineAlso: CymbaltaAdministration of duloxetine | Drug | Control Arm |
Primary outcome
The primary objective is to demonstrate that capsaicin 179 mg patch once compared to duloxetine daily, improves painful CIPN after a 5-week treatment period.
Time frame: 5 weeks
The primary endpoint will be the percentage of painful CIPN patients experiencing a 30% improvement in their average pain severity score at 6 weeks compared to baseline (measured on day 1 of week 6). Patient-reported pain severity will be quantified using the Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF contains four items assessing average, worst, least, and immediate pain severity in the last 24 hours. Pain severity items are scored using an 11-point numeric rating scale (0 = no pain; 10 = pain as bad as you can imagine). In this study, we choose the "average" pain severity score as our primary outcome measure, following recommendations from the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- 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.
Marine TIGREAT contact
François Xavier PILOQUET, MD study director
Institut de Cancérologie de l'Ouest
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Capsaicin and Duloxetine in people with Chemotherapy-induced Peripheral Neuropathy, run by Institut Cancerologie de l'Ouest at 11 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 9 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact François Xavier PILOQUET, MD (+33 2 40 67 99 00, francois-xavier@piloquet@ico.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective is to demonstrate that capsaicin 179 mg patch once compared to duloxetine daily, improves painful CIPN after a 5-week treatment period. (time frame: 5 weeks). 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 31 Mar 2026.