Pepper patch takes on pills for chemo nerve pain
NCT ID NCT05840562
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 3 trial compares a capsaicin patch (applied once) to the daily pill duloxetine for treating painful nerve damage caused by chemotherapy. About 274 people whose nerve pain persists at least a month after chemo will be randomly assigned to one treatment. The goal is to see if the patch can reduce pain by 30% or more after six weeks, offering a potential alternative to daily medication.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- capsaicin patch (Qutenza) and duloxetine (Cymbalta)
- What this could lead to
- If it works, this could offer a new, non-pill option to ease nerve pain from chemotherapy, potentially with fewer side effects than daily oral medication.
- What could go wrong
- This is an open-label study, so both patients and doctors know which treatment is given, which can bias results. Also, capsaicin patches can cause burning or skin irritation, and the trial is still recruiting, so results are not yet available.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 274 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2023
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 * Patient affiliated to a social security scheme * \> 18 years old * Signed written informed consent form Exclusion Criteria: * 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) * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
11 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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"L'Hôpital Privé du Confluent "
RECRUITINGNantes, 44200, France
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CHU Bordeaux
RECRUITINGBordeaux, 33075, France
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CHU Grenoble
RECRUITINGGrenoble, 38043, France
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Centre Antoine Lacassagne
RECRUITINGNice, 06189, France
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Centre François Baclesse
RECRUITINGCaen, 14076, France
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Centre Léon Bérard
RECRUITINGLyon, 69373, France
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Institut Claudius Regaud -IUCT-O
RECRUITINGToulouse, 31059, France
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Institut de Cancérologie Strasbourg Europe
RECRUITINGStrasbourg, 67033, France
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Institut de Cancérologie de l'Ouest
RECRUITINGAngers, 49055, France
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Institut de Cancérologie de l'Ouest
RECRUITINGSaint-Herblain, 44805, France
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Polyclinique Chenieux
RECRUITINGLimoges, 87039, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can TENS, compression, or cold therapy stop chemo nerve pain?
- Can an antidepressant calm Chemotherapy's nerve pain?
- Retraining the senses to fight chemotherapy nerve damage
- Retraining the senses to fight chemotherapy nerve damage
- Chilling out Chemo's side effects: could cold therapy shield nerves?
- Essential oils vs. chemo nerve pain: a natural remedy put to the test