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Chemotherapy Induced Peripheral Neuropathy by Taxanes and Capsaicin 8%. (capsaNeP)

18 de mayo de 2026 actualizado por: Marie PECHARD, Hospital Ambroise Paré Paris

Chemotherapy Induced Peripheral Neuropathy by Taxanes: Pathophysiological Evolution and Somatosensory Response Profile to Capsaicin 8%.

The goal of this study is to compare the evolution of the density of small nerve fibers assessed with skin biopsies at the foot between two groups of patients with taxane-induced chronic neuropathic pain matched for sex and age: one group treated with applications of capsaicin 8% and a control group who received a systemic treatment. The hypothesis for the capsaicin 8% arm is that in the chronic phase, in the absence in the nervous environment of the toxic agent (in this case taxanes) causing the neuropathy and the functional modifications at the origin of pain, the new small fibers could regenerate without these pathological alterations.

Our analysis will be based on the demonstration of structural abnormalities of small nerve fibers by means of skin biopsy, but also of functional abnormalities using four validated tests commonly used in this field: quantitative sensory testing (QST), laser evoked potential recordings, Sudoscan and confocal corneal microscopy.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

The skin biopsies will be performed before the first capsaicin application and before the third application, that is to say 4 to 6 months after the first application. Patients will continue then to be followed for up to one year and another skin punch biopsy will be performed after the fifth 8% capsaicin application (i.e. 8 to 12 months after the first application).

To analyze the relationships between the structural (i.e. fiber density) and functional (i.e. laser evoked potentials (PEL), QST and Sudoscan) changes in small fibers and the clinical effects of the treatment on pain intensity in the 2 groups.

To verify whether the measurement of small corneal fiber density before treatment by the non-invasive technique of corneal confocal microscopy (CCM) (which is known to be correlated with lower limb small fiber density), could be predictive of the response to capsaicin 8%.

An interim analysis will be requested from the ethics committee in France to analyze the data of the first 30 patients

Tipo de estudio

Intervencionista

Inscripción (Estimado)

50

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

  • Nombre: Marie PECHARD, MD
  • Número de teléfono: 3683 0033147111515
  • Correo electrónico: marie.pechard@curie.fr

Ubicaciones de estudio

  • Francia
    • HAUTS DE SEINE
      • Boulogne-Billancourt, HAUTS DE SEINE, Francia, 92100
        • Reclutamiento
        • Inserm U987
        • Contacto:
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • patients over 18 years of age with no age limit
  • having given their signed consent for participation in the study
  • affiliated with the social security system
  • able to be followed for the entire duration of the study
  • reading and understanding French
  • accepting the principle of the study and able to respect its conditions
  • presenting sensorimotor or sensory neuropathy induced by taxanes (paclitaxel or docetaxel) of the lower limbs for at least 3 months based on a complete clinical examination, the severity of which will be assessed by the NCI-CTCAE version 5 criteria (grade 2 to 4). An electromyogram (EMG) will be performed in the absence of a recent electromyogram (less than one year) to assess the function of large fibers, but its normality will not constitute an exclusion criterion (due to the possibility of chemotherapy-induced small fiber neuropathies).
  • presenting chronic neuropathic pain in the lower limbs for at least 3 months, with a DN4 questionnaire score ≥ 4/10 and of at least moderate intensity on an 11-point numerical scale (≥ 4/10)
  • whose pain is located in the lower limbs allowing the application of 8% capsaicin
  • without treatment or having stable analgesic treatment for at least 2 weeks before inclusion

Exclusion Criteria:

  • litigation or compensation-seeking
  • metastatic cancer
  • Known cause of sensory neuropathy such as diabetes, systemic disease, hypothyroidism, alcohol, kidney failure, or genetic disease
  • Peripheral or central nervous system pathology with or without associated neuropathic pain
  • Uncontrolled chronic pathology such as morbid obesity, sleep apnea, uncontrolled hypertension, etc.
  • Psychosis, previous suicide attempt, or major depressive episode at the time of assessment
  • Drug or psychoactive substance abuse
  • Cognitive or psychological disorders incompatible with compliance with and/or understanding of the protocol
  • Patients participating in another biomedical research protocol
  • Contraindications to confocal corneal microscopy, including the wearing of long-term contact lenses or ocular procedures (eye surgery, laser for myopia, dry eye).
  • Pregnant or breastfeeding women
  • Persons under legal protection

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: capsaicin 8%
The minimum time between 2 applications of capsaicin is 60 days, but this could be adapted to the patients' response and therefore could be longer (up to 3 months). Thus, skin biopsies will be performed before the first capsaicin application and before the third application, that is to say 4 to 6 months after the first application. Patients will continue then to be followed for up to one year and another skin punch biopsy will be performed after the fifth 8% capsaicin application (i.e. 8 to 12 months after the first application).
Droga: Capsaicin 8% Patch
The hypothesis is that in the chronic phase, in the absence in the nervous environment of the toxic agent (in this case taxanes) causing the neuropathy and the functional modifications at the origin of pain, the new small fibers could regenerate without these pathological alterations (in particular the changes in the membrane excitability responsible for pain). Thus, capsaicin could, in this specific clinical context, have a "curative" effect on neuropathic pain. However, since the action of capsaicin only concerns small fibers, one cannot expect a global improvement of the neuropathy, which affects all the fibers
Comparador activo: other treatments
Other treatments for neuropathic pain include antidepressants (tricyclics and serotonin reuptake inhibitor SRIs), antiepiletics, lidocaine patches, and neurostimulation according to the 2020 French recommendations.
Droga: antidepressants (tricyclics and serotonin reuptake inhibitor SRIs), antiepiletics, lidocaine patches, and neurostimulation
These treatments are administered to patients according to the French recommendations on the management of neuropathic pain from 2020.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
density of small nerve fibers
Periodo de tiempo: From enrollment to the end of treatment at 12 months

This clinical trial is a pathophysiology protocol. The primary objective of this study is to compare baseline at 3 and 12 months the density of small nerve fibers in the feet using a skin biopsy between two groups of patients with taxane-induced chronic neuropathic pain matched for sex and age.

One group treated with two applications of capsaicin 8% and a control group who received a systemic treatment. All treatments used in the clinical trial are recommended by international experts for treating neurpathic pain and are approved by the French Medicines Agency.
From enrollment to the end of treatment at 12 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
patient reported outcomes and skin biopsy; CCM and skin biopsy; PEL and skin biopsy
Periodo de tiempo: From enrollment to the end of treatment at 12 months.

Correlation between intraepidermal nerve fiber density (skin biopsy) and pain (11-point numerical rating scale, Brief Pain Inventory, Neuropathic Pain Symptom Inventory, EORTC CIPN20, catastrophizing) and other domains to be studied in clinical trials on chronic pain (EQ5D quality of life, PROMIS sleep, IPAQ physical activity, Beck Depression Inventory anxiety).

Correlation between intraepidermal nerve fiber density (skin biopsy) and small nerve fiber functionality (Sudoscan, laser evoked potentials).

Correlation between baseline nerve fiber density assessed by confocal corneal microscopy and the efficacy of 8% capsaicin.
From enrollment to the end of treatment at 12 months.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Hospital Ambroise Paré Paris

Colaboradores

Institut Curie
Grünenthal GmbH

Investigadores

  • Director de estudio: Didier BOUHASSIRA, MD, PhD, Institut National de la Santé Et de la Recherche Médicale, France

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

12 de marzo de 2024

Finalización primaria (Estimado)

1 de marzo de 2027

Finalización del estudio (Estimado)

1 de marzo de 2028

Fechas de registro del estudio

Enviado por primera vez

3 de septiembre de 2025

Primero enviado que cumplió con los criterios de control de calidad

18 de mayo de 2026

Publicado por primera vez (Actual)

22 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

18 de mayo de 2026

Última verificación

1 de septiembre de 2025

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 2023-01
  • 2023-A00325-40 (Otro identificador: 2023-A00325-40)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Descripción del plan IPD

In progress

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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